NCT04292067Recruiting
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Feb 2020
- Start date
- 23 Nov 2020
- Primary completion date
- Nov 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04292067
What you commit to
- Study type: Observational
- Planned participants: 400
- From 23 Nov 2020 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
- Patients had have participated in the prior study Microbiart.
- Healthy control subjects:
- Subjects had have participated in the prior study Microbiart.
Age
- Subjects \< 18 years;
Other
- 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;
- Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
- Foreign patients under french AME scheme;
- Subjects unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- 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;
Who the study is looking for
- 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:
- Adult women and men;
- Subjet free of chronic pathology;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.