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Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
NCT04292067 · Assistance Publique - Hôpitaux de Paris
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.
This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.
Eligibility criteria
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.
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-11-23
Estimated completion: 2026-11
Last updated: 2025-06-15
Interventions
Biological: Faecal samplingBiological: Blood sampling
Primary outcomes
- • Bacteria analysis (At the end of study, up to 4 years)
Sponsor
Assistance Publique - Hôpitaux de Paris · other
Contacts & investigators
ContactMaxime BREBAN, MD, PhD · contact · maxime.breban@aphp.fr · + 33 1 49 09 56 72
InvestigatorMaxime BREBAN, MD, PhD · principal_investigator, Service de Rhumatologie, Hôpital Ambroise Paré, APHP
All locations (1)
Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de ParisRecruiting
Boulogne-Billancourt, France