Status:
RECRUITING
The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spondyloarthritis
Ruminococcus Gnavus
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
As secondary objectives, the study aims: * to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy; * to study the interaction between R. gnavus bacterium and mucus f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04853212
Start Date
June 14 2021
End Date
May 1 2026
Last Update
March 19 2025
Active Locations (1)
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1
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92100