Characterizing gut bacteria in people with spondyloarthritis or rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare intestinal microbiota biodiversity in adults with spondyloarthritis or rheumatoid arthritis versus healthy volunteers using DNA sequencing of stool samples and parallel blood sampling. The primary aim is to look for disease-specific dysbiosis and identify bacterial biomarkers that differ between the groups. Secondary analyses will relate microbiota composition to clinical factors such as age, sex, disease duration, and ongoing treatments, and will compare faecal and plasma metabolomes with microbiota profiles. The work is performed in the rheumatology department at Hôpital Ambroise Paré (Assistance Publique–Hôpitaux de Paris) and involves collection of stool and blood samples from consenting adults.

Why it matters

Who can join: the full rules

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.

Where it's running

• Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
  Boulogne-Billancourt, France Recruiting

Study contacts

• Principal investigator: Maxime BREBAN, MD, PhD — Service de Rhumatologie, Hôpital Ambroise Paré, APHP
• Study coordinator: Maxime BREBAN, MD, PhD
• Email: maxime.breban@aphp.fr
• Phone: + 33 1 49 09 56 72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.