Faecal microbiota study reveals specific dysbiosis in spondyloarthritis.
Maxime Breban, Julien Tap, Ariane Leboime...
https://pubmed.ncbi.nlm.nih.gov/28606969Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID04292067
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-15
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the differences in intestinal microbiota between patients with spondyloarthritis (SPA) or rheumatoid arthritis (RA) and healthy volunteers. The study aims to compare the biodiversity of gut bacteria by DNA sequencing to identify specific bacterial markers associated with each disease. Additionally, the study explores how clinical factors like age, gender, disease duration, and ongoing treatments relate to the gut microbiota composition and the connection between faecal and plasma metabolomes and intestinal bacteria. Participants include groups of 100 SPA patients, 100 RA patients, and 200 healthy control subjects. Biological samples of feces and blood are collected at the beginning of the study to analyze the microbiota. This observational research is conducted at the rheumatology department of Ambroise Paré hospital in France, focusing on gathering detailed data without administering treatments. Throughout the study, participants provide samples for bacterial and microbiota composition analysis, which are assessed up to four years after enrollment. Researchers monitor the gut bacteria profiles and their relation to clinical parameters over time. The study includes both patients and healthy adults, with evaluations centered on understanding microbiota differences and identifying potential biomarkers for SPA and RA.
CONDITIONS
Brief Title
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with spondyloarthritis according to ASAS classification or rheumatoid polyarthritis according to ACR/EULAR
- Affiliated to a social security scheme
- Have signed the written informed consent form
- Adult women and men healthy control subjects
- Healthy controls must be free of chronic pathology
- Healthy controls affiliated to a social security scheme
- Healthy controls have signed the written informed consent form
You will not qualify if you...
- Unable to understand the study or sign informed consent
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
- Patients who have taken antibiotics within 1 month prior to inclusion
- Patients who had digestive colonoscopy within 6 months prior to inclusion
- Presenting acute or chronic severe pathology likely to interfere with outcome interpretation
- Foreign patients under French AME scheme
- Patients or healthy subjects who participated in the prior Microbiart study
- Healthy subjects under 18 years
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Sample Collection
Duration - At baseline
Participants provide faecal and blood samples to analyze the intestinal microbiota and related metabolome.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 4 years
Participants are observed over time to study the composition of intestinal microbiota and its relation to clinical parameters.
Visits as needed for sample collection and assessments
Trial Site Locations
Total: 1 location
1
Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, France, 92100
Actively Recruiting
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Research Team
M
Maxime BREBAN, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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