SpondylarthropathiesMESAJNCT04540432
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment
A study testing Stool collection at the patient's home. and Blood test in people with Spondylarthropathies, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spondylarthropathies
- What is being tested?
- Stool collection at the patient's home. and Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Sep 2021to 28 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged over 6 and under 17 years old (included).
- Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria.
- Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months.
- Patients who haven't been treated by cortisone for over a month.
- Patients whose parents have given written informed consent.
- Patients for whom the consent form has been signed by their legal guardian.
- Patients covered by the Social Security System or benefitting from private health insurance.
Who cannot join
- Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion.
- Patients who are within an exclusion period determined by another study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
APHM, Hopital Nord
Marseille
Anne-Laure JURQUET
- Recruiting
Montpellier University Hospital, Arnaud de Villeneuve Hospital
Montpellier, Hérault, 34295
Eric JEZIORSKI, Dr., +33 4 67 33 22 86, e-jeziorski@chu-montpellier.fr
Eric JEZIORSKI, Dr.
- Recruiting
Nîmes University Hospital
Nîmes, Gard, 30029
Anissa MEGZARI, +33 4 66 68 42 36, drc@chu-nimes.fr
Tu-Anh TRAN, Prof.
- Not yet recruiting
Hopital des enfants, CHU de Toulouse
Toulouse
Ariane BENEZECH, benezech.a@chu-toulouse.fr, benezech.a@chu-toulouse.fr
About this study
Official title: Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study
Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.
- Conditions
- Spondylarthropathies
- Being tested
- Stool collection at the patient's home., Blood test
- Keywords
- Microbiota
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collection at the patient's home.Other
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.
Blood testDiagnostic test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Profile AB | Experimental | Patients on non-steroidal anti-inflammatory drugs followed by biotherapy. Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
| Profile AM | Experimental | Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate. Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
| Profile AMB | Experimental | Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate. Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
| Profile A | Experimental | Patients on non-steroidal anti-inflammatory drugs. Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
| Profile M | Experimental | methotrexate alone Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
| Profile B | Experimental | biotherapy alone Receives: Other: Stool collection at the patient's home.; Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
- the diversity index according to the number of species and the number of functional groups.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 1 month of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
- the physician's global assessment of disease activity;
- the parent/guardian's or patient's global assessment of overall wellbeing;
- number of joints with active arthritis; and
- C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Measured: After 1 month of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) will be noted.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
- the physician's global assessment of disease activity;
- the parent/guardian's or patient's global assessment of overall wellbeing;
- number of joints with active arthritis; and
- C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM) will be noted.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
- the physician's global assessment of disease activity;
- the parent/guardian's or patient's global assessment of overall wellbeing;
- number of joints with active arthritis; and
- C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) will be noted.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: 24 hours after inclusion
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 1 month of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Measured: After 6 months of treatment
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
- the physician's global assessment of disease activity;
- the parent/guardian's or patient's global assessment of overall wellbeing;
- number of joints with active arthritis; and
- C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Measured: After 6 months of treatment
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB) will be noted.
Measured: After 6 months of treatment
Secondary outcomes (52)
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: After 1 month of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: After 6 months of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: 24 hours after inclusion
A: Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: After 6 months of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Measured: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: After 1 month of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Measured: After 6 months of treatment
C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
All blood and stool samples used for the study will be deposited in the biobank for reference.
Measured: After 6 months of treatment
C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).
All blood and stool samples used for the study will be deposited in the biobank for reference.
Measured: After 6 months of treatment
C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
All blood and stool samples used for the study will be deposited in the biobank for reference.
Measured: At the inclusion visit on Day 0
C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
All blood and stool samples used for the study will be deposited in the biobank for reference.
Measured: At the inclusion visit on Day 0
Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in years
Measured: At the inclusion visit on Day 0
Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in kilos
Measured: At the inclusion visit on Day 0
Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in cm.
Measured: At the inclusion visit on Day 0
Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Male/Female
Measured: At the inclusion visit on Day 0
Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
- NSAIDs : dosage and dates
- Corticoids : dosage and dates
- Antibiotics : dosage and dates
- DMARDs : dosage and dates
Measured: At the inclusion visit on Day 0
Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of patients' dietary habits and, more particularly, note all foods which are excluded.
Measured: At the inclusion visit on Day 0
Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of patients' food allergies.
Measured: At the inclusion visit on Day 0
Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of the patient's lifestyle:
- Brothers and sisters (number and date of birth of each one)
- Communities (date of entry)
- Contact with animals
Measured: At the inclusion visit on Day 0
Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in years
Measured: At the inclusion visit on Day 0
Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in kilos
Measured: At the inclusion visit on Day 0
Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in cm.
Measured: At the inclusion visit on Day 0
Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Male/Female
Measured: At the inclusion visit on Day 0
Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
- NSAIDs : dosage and dates
- Corticoids : dosage and dates
- Antibiotics : dosage and dates
- DMARDs : dosage and dates
Measured: At the inclusion visit on Day 0
Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Measured: At the inclusion visit on Day 0
Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all patients' food allergies.
Measured: At the inclusion visit on Day 0
Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of the patient's lifestyle:
- Brothers and sisters (number and date of birth of each one)
- Communities (date of entry)
- Contact with animals
Measured: At the inclusion visit on Day 0
Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Recorded in years
Measured: At the inclusion visit on Day 0
Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Recorded in kilos
Measured: At the inclusion visit on Day 0
Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)
Recorded in cm.
Measured: At the inclusion visit on Day 0
Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Male/Female
Measured: At the inclusion visit on Day 0
Previous treatment in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
- NSAIDs : dosage and dates
- Corticoids : dosage and dates
- Antibiotics : dosage and dates
- DMARDs : dosage and dates
Measured: At the inclusion visit on Day 0
Dietary habits in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Measured: At the inclusion visit on Day 0
Food allergies in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all patients' food allergies.
Measured: At the inclusion visit on Day 0
Lifestyle in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of the patient's lifestyle:
- Brothers and sisters (number and date of birth of each one)
- Communities (date of entry)
- Contact with animals
Measured: At the inclusion visit on Day 0
Age of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate biotherapy)
Recorded in years
Measured: At the inclusion visit on Day 0
Weight of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Recorded in kilos
Measured: At the inclusion visit on Day 0
Height of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Recorded in cm.
Measured: At the inclusion visit on Day 0
Sex of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Male/Female
Measured: At the inclusion visit on Day 0
Previous treatment in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
- NSAIDs : dosage and dates
- Corticoids : dosage and dates
- Antibiotics : dosage and dates
- DMARDs : dosage and dates
Measured: At the inclusion visit on Day 0
Dietary habits in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Measured: At the inclusion visit on Day 0
Food allergies in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all patients' food allergies.
Measured: At the inclusion visit on Day 0
Lifestyle in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of the patient's lifestyle:
- Brothers and sisters (number and date of birth of each one)
- Communities (date of entry)
- Contact with animals
Measured: At the inclusion visit on Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start22 Sep 2021
- Primary completion28 Jun 2029 (estimated)
- Study completion28 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthropathiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be split into 4 groups according to their treatment profile: Profile A = patients on non-steroidal anti-inflammatory drugs. Profile AM = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate until the end of the study. Profile AB = patients on non-steroidal anti-inflammatory drugs, followed by biotherapy until the end of the study. Profile AMB = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy until the end of the study. Profile M : methotrexate alone Profile B : biothérapy alone
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540432
- Sponsor's protocol ID
- NIMAO/2019/TAT-01
- Other IDs
- 20.03.20.564
- Acronym
- MESAJ
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04540432
- Acronym / sponsor ID
- MESAJ / NIMAO/2019/TAT-01
- Conditions
- Spondylarthropathies
- Keywords
- Microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier, Assistance Publique Hopitaux De Marseille
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 28 Jun 2029 (estimated)
- Study completion
- 28 Jun 2029 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Patients will be split into 4 groups according to their treatment profile: Profile A = patients on non-steroidal anti-inflammatory drugs. Profile AM = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate until the end of the study. Profile AB = patients on non-steroidal anti-inflammatory drugs, followed by biotherapy until the end of the study. Profile AMB = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy until the end of the study. Profile M : methotrexate alone Profile B : biothérapy alone
| Arm | Type | Receives |
|---|---|---|
| Profile AB | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testPatients on non-steroidal anti-inflammatory drugs followed by biotherapy. |
| Profile AM | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testPatients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate. |
| Profile AMB | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testPatients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate. |
| Profile A | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testPatients on non-steroidal anti-inflammatory drugs. |
| Profile M | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testmethotrexate alone |
| Profile B | Experimental | Other: Stool collection at the patient's home., Diagnostic Test: Blood testbiotherapy alone |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients aged over 6 and under 17 years old (included).
- Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria.
- Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months.
- Patients who haven't been treated by cortisone for over a month.
- Patients whose parents have given written informed consent.
Key exclusion criteria (2 listed)
- Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion.
- Patients who are within an exclusion period determined by another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool collection at the patient's home.Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment. | Other | Profile A, Profile AB, Profile AM, Profile AMB, Profile B, Profile M |
| Blood test7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment. | Diagnostic test | Profile A, Profile AB, Profile AM, Profile AMB, Profile B, Profile M |
Primary outcome
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded. - the diversity index according to the number of species and the number of functional groups.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Time frame: After 1 month of treatment
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.
Time frame: After 1 month of treatment
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species detected in the intestinal microbiota.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)
Time frame: After 6 months of treatment
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM). Number of flare-ups.
Time frame: After 6 months of treatment
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Time frame: After 6 months of treatment
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.
Time frame: After 6 months of treatment
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Time frame: 24 hours after inclusion
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Time frame: After 1 month of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Time frame: After 6 months of treatment
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Time frame: After 6 months of treatment
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.
Time frame: After 6 months of treatment
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB) will be noted.
52 secondary outcomes
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: After 1 month of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: After 6 months of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: 24 hours after inclusion
A: Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: After 6 months of treatment
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: 24 hours after inclusion
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Time frame: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Time frame: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Time frame: After 1 month of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Time frame: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Time frame: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Time frame: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Time frame: After 6 months of treatment
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Time frame: 24 hours after inclusion
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Time frame: After 6 months of treatment
C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: After 6 months of treatment
C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).
Time frame: After 6 months of treatment
C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Time frame: At the inclusion visit on Day 0
C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Time frame: At the inclusion visit on Day 0
Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Time frame: At the inclusion visit on Day 0
Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Time frame: At the inclusion visit on Day 0
Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Time frame: At the inclusion visit on Day 0
Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Time frame: At the inclusion visit on Day 0
Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)
Time frame: At the inclusion visit on Day 0
Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Time frame: At the inclusion visit on Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool collection at the patient's home. and Blood test in people with Spondylarthropathies, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tu-Anh TRAN, Professor (+33 4 66 32 86, tu.anh.tran@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota. (time frame: 24 hours after inclusion). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.