NCT04853212 The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
| NCT ID | NCT04853212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-06-14 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-06-14 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).
Eligibility Criteria
Inclusion Criteria: Patients with SPA: * Patients ⩾ 18 years; * Diagnosed as spondyloarthritis (SpA) according ASAS classification; * Affiliated to a social security scheme; * Have signed the written informed consent form. Control subjects: * Subjects ⩾ 18 years; * Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member; * Affiliated to a social security scheme; * Have signed the written informed consent form. Exclusion Criteria: * 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; * Have taken antibiotic 1 month prior to inclusion; * 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.
Contact & Investigator
Maxime BREBAN, MD, PhD
PRINCIPAL INVESTIGATOR
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Frequently Asked Questions
Who can join the NCT04853212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04853212 currently recruiting?
Yes, NCT04853212 is actively recruiting participants. Contact the research team at maxime.breban@aphp.fr for enrollment information.
Where is the NCT04853212 trial being conducted?
This trial is being conducted at Boulogne-Billancourt, France.
Who is sponsoring the NCT04853212 clinical trial?
NCT04853212 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Maxime BREBAN, MD, PhD at Service de Rhumatologie, Hôpital Ambroise Paré, APHP. The trial plans to enroll 100 participants.