Characterizing gut bacteria in people with spondyloarthritis or rheumatoid arthritis

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

This project will test whether the mix of gut bacteria differs between adults with spondyloarthritis or rheumatoid arthritis and healthy volunteers by analyzing stool and blood samples.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Boulogne-Billancourt)
• Trial ID: NCT04292067 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) diagnosed with spondyloarthritis by ASAS criteria or rheumatoid arthritis by ACR/EULAR, who can give informed consent, are affiliated to a French social security scheme, and have not taken antibiotics in the month before inclusion or had a colonoscopy in the prior six months.

Not a fit: People who are pregnant or breastfeeding, under guardianship, have recent antibiotic use or recent colonoscopy, severe comorbidities that interfere with interpretation, or non-French social-security status are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify bacterial biomarkers that help diagnose subtypes of spondyloarthritis or rheumatoid arthritis or guide more personalized treatments.

How similar studies have performed: Previous microbiome studies have reported disease-associated dysbiosis in rheumatoid arthritis and spondyloarthritis, but consistent diagnostic biomarkers are not yet established, so this work builds on suggestive but not definitive findings.

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.

Where this trial is running

Boulogne-Billancourt

• 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

Conditions: Spondyloarthritis, Rheumatoid Arthritis, Microbiota