Arthritis, RheumatoidMICROPOLYNCT01961310
Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA. The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Plasma analysis for bacterial translocation and Stool analysis
- How many people
- 55 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Mar 2016to 29 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 50 adult subjects will be included: 25 with newly diagnosed RA (<12 months) based on the American College of Rheumatology criteria, and 25 healthy volunteers without RA.
Who may be able to join
- The patient was correctly informed
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- No antibiotic treatments within the 30 days preceding inclusion
- Absence of digestive pathology
- RA diagnosis made within the past 12 months
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- The HV was correctly informed
- The HV must have given his/her informed and signed consent
- The HV must be insured or beneficiary of a health insurance plan
- Absence of digestive pathology
- No antibiotic treatments within the 30 days preceding inclusion
- Does not have RA
Who cannot join
- The patient has participated in another study within the past 3 months
- The patient is under judicial protection, or any kind of guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has taken antibiotics in the 30 days preceding inclusion
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- RA was diagnosed more than 12 months ago
- Digestive pathology
- The HV has participated in another study within the past 3 months
- The HV is under judicial protection, or any kind of guardianship
- The HV refuses to sign the consent
- It is impossible to correctly inform the HV
- The HV is pregnant, parturient, or breastfeeding
- The HV has taken antibiotics in the 30 days preceding inclusion
- Digestive pathology
- Joint pathology of any kind (including inflammatory pathologies)
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine
Nîmes, 30908
About this study
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.
The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.
Read the detailed description
The secondary objectives of this study are :
- A. To compare between the two groups :
- a. The proportion of Proteus mirabilis in the intestinal microbiota;
- b . The proportion of species producing peptidyl arginine deaminase (PAD ) in the intestinal microbiota;
- c . The number of species found in the intestinal microbiota.
- B. To evaluate bacterial translocation (from the digestive tract) in newly diagnosed RA patients with and healthy volunteers without RA. (Bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. LPS teichoïc acid) cross the intestinal barrier and reach the bloodstream.).
- C. To describe the ecology of the intestinal microbiota of newly diagnosed RA patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with RA than in individuals without RA).
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Plasma analysis for bacterial translocation, Stool analysis
- Keywords
- bacterial translocation, intestinal microbiota
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma analysis for bacterial translocationBiological
1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.
Stool analysisBiological
DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.
| Study group | Role | What they receive |
|---|---|---|
| RA patients | This group is composed of 25 patients with RA. The diagnosis of RA is based upon the American College of Rheumatology criteria.
* Intervention: Plasma analysis for bacterial translocation
* Intervention: Stool analysis Receives: Biological: Plasma analysis for bacterial translocation; Biological: Stool analysis | |
| Healthy voluteers | This group is composed of 25 healthy volunteers.
* Intervention: Plasma analysis for bacterial translocation
* Intervention: Stool analysis Receives: Biological: Plasma analysis for bacterial translocation; Biological: Stool analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of filamentous bacteria in the intestinal microbiota
Measured: Baseline (day 0)
Secondary outcomes (5)
The proportion of Proteus mirabilis in the intestinal microbiota
Measured: baseline (Day 0)
The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota
Measured: baseline (Day 0)
The number of species found in the intestinal microbiota
Measured: baseline (Day 0)
Presence/absence of bacterial translocation
Measured: baseline (Day 0)
Description of the ecology of intestinal microbiota
Diversity indices according to species and/or functional groups. The general goal is to provide a description of the functional differences between groups.
Measured: baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study start8 Mar 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Dunyach-Rempy, PharmD, PhD, Study director, Centre Hospitalier Universitaire de NīmesJean Philippe Lavigne, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961310
- Sponsor's protocol ID
- AOIt/2012/JPL-01
- Other IDs
- 2014-A01753-44
- Acronym
- MICROPOLY
- Status last verified
- Jul 2020
- First submitted
- 9 Oct 2013
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunyach-Remy C, Pouget C, Pers YM, Gaujoux-Viala C, Demattei C, Salipante F, Grenga L, Armengaud J, Lavigne JP, Jorgensen C. Participation of gut microbiota and bacterial translocation in chronic systemic inflammation in recently diagnosed rheumatoid arthritis patients. Curr Res Microb Sci. 2025 Feb 24;8:100366. doi: 10.1016/j.crmicr.2025.100366. eCollection 2025.
PubMed 40123592
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01961310
- Acronym / sponsor ID
- MICROPOLY / AOIt/2012/JPL-01
- Conditions
- Arthritis, Rheumatoid
- Keywords
- bacterial translocation, intestinal microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 11 Oct 2013 (estimated)
- 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.
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.
The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.
Detailed description
The secondary objectives of this study are :
- A. To compare between the two groups :
- a. The proportion of Proteus mirabilis in the intestinal microbiota;
- b . The proportion of species producing peptidyl arginine deaminase (PAD ) in the intestinal microbiota;
- c . The number of species found in the intestinal microbiota.
- B. To evaluate bacterial translocation (from the digestive tract) in newly diagnosed RA patients with and healthy volunteers without RA. (Bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. LPS teichoïc acid) cross the intestinal barrier and reach the bloodstream.).
- C. To describe the ecology of the intestinal microbiota of newly diagnosed RA patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with RA than in individuals without RA).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | Biological: Plasma analysis for bacterial translocation, Biological: Stool analysisThis group is composed of 25 patients with RA. The diagnosis of RA is based upon the American College of Rheumatology criteria. * Intervention: Plasma analysis for bacterial translocation * Intervention: Stool analysis |
| Healthy voluteers | – | Biological: Plasma analysis for bacterial translocation, Biological: Stool analysisThis group is composed of 25 healthy volunteers. * Intervention: Plasma analysis for bacterial translocation * Intervention: Stool analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 adult subjects will be included: 25 with newly diagnosed RA (<12 months) based on the American College of Rheumatology criteria, and 25 healthy volunteers without RA.
Key inclusion criteria (12 listed)
- The patient was correctly informed
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- No antibiotic treatments within the 30 days preceding inclusion
- Absence of digestive pathology
Key exclusion criteria (16 listed)
- The patient has participated in another study within the past 3 months
- The patient is under judicial protection, or any kind of guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
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 |
|---|---|---|
| Plasma analysis for bacterial translocation1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed. | Biological | Healthy voluteers, RA patients |
| Stool analysisDNA from stool samples will be extracted, amplified, and used to identify the bacteria species present. | Biological | Healthy voluteers, RA patients |
Primary outcome
The proportion of filamentous bacteria in the intestinal microbiota
Time frame: Baseline (day 0)
5 secondary outcomes
The proportion of Proteus mirabilis in the intestinal microbiota
Time frame: baseline (Day 0)
The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota
Time frame: baseline (Day 0)
The number of species found in the intestinal microbiota
Time frame: baseline (Day 0)
Presence/absence of bacterial translocation
Time frame: baseline (Day 0)
Description of the ecology of intestinal microbiota
Time frame: baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 40123592Dunyach-Remy C, Pouget C, Pers YM, Gaujoux-Viala C, Demattei C, Salipante F, Grenga L, Armengaud J, Lavigne JP, Jorgensen C. Participation of gut microbiota and bacterial translocation in chronic systemic inflammation in recently diagnosed rheumatoid arthritis patients. Curr Res Microb Sci. 2025 Feb 24;8:100366. doi: 10.1016/j.crmicr.2025.100366. eCollection 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. This study is not recruiting at the moment.
Catherine Dunyach-Rempy, PharmD, PhD study director
Centre Hospitalier Universitaire de Nīmes
Jean Philippe Lavigne, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Nīmes at 3 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 12 inclusion and 16 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: finished, as of the sponsor's last update on 21 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of filamentous bacteria in the intestinal microbiota (time frame: Baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01961310, which also lists 1 linked publication.
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 21 Nov 2025.