Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
NCT ID: NCT04292067
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-11-23
2026-11-30
Brief Summary
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Detailed Description
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This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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patients with SPA
100 SPA patients
Faecal sampling
Faecal sampling at baseline
Blood sampling
Blood sampling at baseline
Healthy subjets
200 healthy subjets in control group
Faecal sampling
Faecal sampling at baseline
Blood sampling
Blood sampling at baseline
patients with RA
100 RA patients
Faecal sampling
Faecal sampling at baseline
Blood sampling
Blood sampling at baseline
Interventions
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Faecal sampling
Faecal sampling at baseline
Blood sampling
Blood sampling at baseline
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Maxime BREBAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Locations
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Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
Other Identifiers
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2019-A02632-55
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP190991
Identifier Type: -
Identifier Source: org_study_id
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