SpondyloarthritisMICROBIARTNCT04292067
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
An observational study of Spondyloarthritis and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthritis, Rheumatoid Arthritis
- What is being tested?
- Faecal sampling and Blood sampling
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2020to Nov 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis; * Healthy adult subjects free of chronic pathology.
Who may be able to join
- Patients:
- Patient ⩾ 18 years;
- Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
- Healthy control subjects:
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- Adult women and men;
- Subjet free of chronic pathology;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
Who cannot join
- Patients:
- Patients unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- Patient ⩾ 18 years;
- Patients under guardianship or curatorship;
- Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
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- Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
- Foreign patients under french AME scheme;
- Patients had have participated in the prior study Microbiart.
- Healthy control subjects:
- Subjects unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- Subjects < 18 years;
- Subjects under guardianship or curatorship;
- Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
- Refusal of subjects to participate to the study;
- Foreign patients under french AME scheme;
- Subjects had have participated in the prior study Microbiart.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, 92100
Maxime BREBAN, MD, PhD, +33 1 49 09 56 72, maxime.breban@aphp.fr
About this study
The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.
Read the detailed description
As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.
This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis
- Being tested
- Faecal sampling, Blood sampling
- Keywords
- Spondyloarthritis, Rheumatoid Arthritis, Microbiota
- Medical subject headings
- Spondylarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal samplingBiological
Faecal sampling at baseline
Blood samplingBiological
Blood sampling at baseline
| Study group | Role | What they receive |
|---|---|---|
| patients with SPA | 100 SPA patients Receives: Biological: Faecal sampling; Biological: Blood sampling | |
| Healthy subjets | 200 healthy subjets in control group Receives: Biological: Faecal sampling; Biological: Blood sampling | |
| patients with RA | 100 RA patients Receives: Biological: Faecal sampling; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteria analysis
Quantitative analysis of repartition of bacteria in each group and the comparison between groups.
Measured: At the end of study, up to 4 years
Secondary outcomes (1)
Intestinal microbiota composition
Intestinal microbiota composition will be analysed
Measured: At the end of study, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start23 Nov 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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 SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime BREBAN, MD, PhD, Principal investigator, Service de Rhumatologie, Hôpital Ambroise Paré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292067
- Sponsor's protocol ID
- APHP190991
- Other IDs
- 2019-A02632-55
- Acronym
- MICROBIART
- Status last verified
- May 2025
- First submitted
- 26 Feb 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
PubMed 28606969
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04292067
- Acronym / sponsor ID
- MICROBIART / APHP190991
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis
- Keywords
- Spondyloarthritis, Rheumatoid Arthritis, Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Mar 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.
The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.
Detailed description
As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.
This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with SPA | – | Biological: Faecal sampling, Biological: Blood sampling100 SPA patients |
| Healthy subjets | – | Biological: Faecal sampling, Biological: Blood sampling200 healthy subjets in control group |
| patients with RA | – | Biological: Faecal sampling, Biological: Blood sampling100 RA patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis; * Healthy adult subjects free of chronic pathology.
Key inclusion criteria (10 listed)
- Patient ⩾ 18 years;
- Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
- Adult women and men;
Key exclusion criteria (18 listed)
- Patients unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- Patient ⩾ 18 years;
- Patients under guardianship or curatorship;
- Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
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 |
|---|---|---|
| Faecal samplingFaecal sampling at baseline | Biological | Healthy subjets, patients with RA, patients with SPA |
| Blood samplingBlood sampling at baseline | Biological | Healthy subjets, patients with RA, patients with SPA |
Primary outcome
Bacteria analysis
Time frame: At the end of study, up to 4 years
Quantitative analysis of repartition of bacteria in each group and the comparison between groups.
1 secondary outcome
Intestinal microbiota composition
Time frame: At the end of study, up to 4 years
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 15 Jun 2025.
- Background: PubMed 28606969Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
- Individual participant dataSharing planned: No
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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.
Maxime BREBAN, MD, PhD principal investigator
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 10 inclusion and 18 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 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Maxime BREBAN, MD, PhD (+ 33 1 49 09 56 72, maxime.breban@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteria analysis (time frame: At the end of study, up to 4 years). 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 NCT04292067, 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 15 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.