Status:
RECRUITING
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spondyloarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief 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 ...
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 comp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04292067
Start Date
November 23 2020
End Date
November 1 2026
Last Update
June 15 2025
Active Locations (1)
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1
Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, France, 92100