Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID03983473

Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease

Led by Central Hospital, Nancy, France · Updated on 2026-02-03

240

Participants Needed

2

Research Sites

6 weeks

Total Duration

On this page

Sponsors

C

Central Hospital, Nancy, France

Lead Sponsor

C

Centre Hospitalier Régional Metz-Thionville

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the gut microbiota, serum cytokines, and peripheral blood mononuclear cells (PBMC) in patients with Crohn's disease (CD) alone, spondyloarthritis (SpA) alone, both conditions, and healthy controls. The goal is to identify differences in the fecal microbiota through bacteriome, virome, and fungome sequencing. This project aims to better understand the biological markers associated with these diseases and their overlap. Participants are divided into four groups: those with Crohn's disease without spondyloarthritis, those with spondyloarthritis without Crohn's disease, those with both conditions, and healthy individuals. Stool samples will be collected for next-generation sequencing (NGS) to analyze the diversity of bacteria, viruses, and fungi present in the gut. This process focuses on detailed microbiota profiling without involving drug treatments. During the study, researchers will measure the alpha and beta diversity of fecal bacteriome, fungome, and virome at baseline and after six months. Participants will provide stool samples and undergo clinical assessments. The study involves monitoring these biological markers over time to observe changes or patterns associated with the presence of Crohn's disease, spondyloarthritis, or both. The total duration for participants includes follow-up at six months for outcome measurement.

CONDITIONS

Brief Title

Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients with Crohn's disease and axial spondyloarthritis
  • Patients with Crohn's disease diagnosed by clinical, biological, radiological, endoscopic, or histological studies for at least 3 months, excluding spondyloarthritis
  • Patients with axial spondyloarthritis diagnosed by modified ASAS or New York criteria, excluding Crohn's disease
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • History of colonic resection
  • Use of antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection
  • Presence of ostomy at the time of sampling
  • Body mass index (BMI) greater than 30
  • Extreme diet
  • Unbalanced diabetes
  • Pregnancy
  • Under guardianship, curatorship, or legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 6 months

Participants are observed to identify fecal microbiota biomarkers related to spondyloarthritis and Crohn's disease.

1 visit at baseline and 1 follow-up visit at 6 months

Trial Site Locations

Total: 2 locations

1

Central Hospital

Nancy, Lorraine, France, 54500

Actively Recruiting

2

Saint Antoine Hospital

Paris, France, 75012

Actively Recruiting

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Research Team

L

Laurent MD PEYRIN-BIROULET, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

4

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