Exploring the link between gut bacteria and spondyloarthritis
The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
This study is testing if a specific gut bacteria called Ruminococcus gnavus is linked to spondyloarthritis by comparing patients with the condition to healthy people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Boulogne-Billancourt) |
| Trial ID | NCT04853212 on ClinicalTrials.gov |
What this trial studies
This case-control study investigates the role of the bacterium Ruminococcus gnavus in the development of spondyloarthritis by comparing patients with the condition to healthy controls. It involves intestinal biopsies and fecal sampling to assess the abundance of R. gnavus and its interactions with intestinal mucus and epithelial cells. The study also aims to correlate gene expression in intestinal mucus with variations in microbiota and to demonstrate immune response perturbations caused by dysbiosis.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with spondyloarthritis and those undergoing digestive endoscopy for unrelated reasons.
Not a fit: Patients who are pregnant, breastfeeding, or have taken antibiotics recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the role of gut microbiota in spondyloarthritis, potentially guiding future treatments.
How similar studies have performed: While the role of gut microbiota in various conditions has been explored, this specific investigation into R. gnavus and spondyloarthritis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boulogne-Billancourt
- Service de Rhumatologie, Hôpital Ambroise Paré, APHP — Boulogne-Billancourt, France (Recruiting)
Study contacts
- Principal investigator: Maxime BREBAN, MD, PhD — Service de Rhumatologie, Hôpital Ambroise Paré, APHP
- Study coordinator: Maxime BREBAN, MD, PhD
- Email: maxime.breban@aphp.fr
- Phone: +33 1 49 09 56 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.