Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04853212

The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-19

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the role of the bacterium Ruminococcus gnavus in the development of spondyloarthritis (SpA) compared to healthy individuals undergoing digestive endoscopy. This study aims to understand how this bacterium may be involved in starting and progressing SpA by examining intestinal biopsies and fecal samples. Secondary goals include studying the abundance of R. gnavus, its interaction with intestinal mucus and epithelial cells, gene expression of intestinal mucus, and immune response changes caused by microbial imbalance. Participants will be grouped into those diagnosed with SpA and healthy control subjects who are scheduled for digestive endoscopy for other reasons. The study involves collecting biopsy samples during recto-colonoscopy to analyze the presence and characteristics of R. gnavus. Both groups will undergo similar procedures, and researchers will observe differences in bacterial abundance and interactions within the intestinal environment. During the study, which may last up to two years, participants will have intestinal biopsies and fecal samples collected. Researchers will perform bacterial analyses, RNA sequencing, and cell culture experiments to assess bacteria interactions and immune responses. The main outcomes include isolating and characterizing R. gnavus and understanding its role in SpA development. Participants will be monitored for these outcomes without additional treatment interventions.

CONDITIONS

Brief Title

The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older diagnosed with spondyloarthritis according to ASAS classification
  • Affiliated to a social security scheme
  • Able to provide written informed consent
  • Control subjects aged 18 years or older without spondyloarthritis and scheduled for digestive endoscopy
  • Control subjects affiliated to a social security scheme
  • Control subjects able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to understand the study or provide informed consent
  • Pregnant or breastfeeding women
  • Subjects under guardianship or curatorship
  • Taken antibiotics within 1 month prior to inclusion
  • Have acute or chronic severe conditions that may interfere with study results
  • Refusal to participate in the study
  • Foreign patients under French AME scheme

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Biopsy Procedure

Duration - At one point during the study

Participants undergo a biopsy during recto-coloscopy to collect mucosal samples for analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are observed over time to study changes in intestinal microbiota and immune responses related to spondyloarthritis.

Trial Site Locations

Total: 1 location

1

Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, France, 92100

Actively Recruiting

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Research Team

M

Maxime BREBAN, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases.

Emmanuelle H Crost, Louise E Tailford, Marie Monestier...

https://pubmed.ncbi.nlm.nih.gov/27223845