RecruitingNCT04292067
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
400 participants
Start Date
Nov 23, 2020
Study Type
OBSERVATIONAL
Conditions
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 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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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 Criteria18
- 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.
Interventions
BIOLOGICALFaecal sampling
Faecal sampling at baseline
BIOLOGICALBlood sampling
Blood sampling at baseline
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04292067
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