EICHORCondition: Spondyloarthritis · Rheumatoid Arthritis · Sponsor: Assistance Publique - Hôpitaux de Paris
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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.
This description comes directly from the study's public registry record.
Maxime BREBAN, MD, PhD · + 33 1 49 09 56 72 · maxime.breban@aphp.fr
There is no obligation to join — the study team can answer your questions about taking part.
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Inclusion Criteria: 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 Criteria: 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris | Boulogne-Billancourt, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04292067