The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Last updated: March 17, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ankylosing Spondylitis

Connective Tissue Diseases

Treatment

Biopsy

Clinical Study ID

NCT04853212
APHP210332
2020-A03244-35
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with SPA:

  • Patients ⩾ 18 years;

  • Diagnosed as spondyloarthritis (SpA) according ASAS classification;

  • Affiliated to a social security scheme;

  • Have signed the written informed consent form.

Control subjects:

  • Subjects ⩾ 18 years;

  • Subjects free of SPA and planned for a digestive endoscopy for another indicationsuch as to explore the risk of colorectal cancer in family member;

  • Affiliated to a social security scheme;

  • Have signed the written informed consent form.

Exclusion

Exclusion Criteria:

  • Subjects unable to understand the proposed study and/or sign a informed consentform;

  • Pregnant women or breast feeding women;

  • Subjects under guardianship or curatorship;

  • Have taken antibiotic 1 month prior to inclusion;

  • Presenting acute or chronic severe pathology may likely to interfere with theinterpret of outcome;

  • Refusal of subjects to participate to the study;

  • Foreign patients under french AME scheme.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Biopsy
Phase:
Study Start date:
June 14, 2021
Estimated Completion Date:
May 31, 2026

Study Description

As secondary objectives, the study aims:

  • to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy;

  • to study the interaction between R. gnavus bacterium and mucus from histological sampling;

  • to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy;

  • to study the interaction between bacteria and intestinal epithelial cells during culture;

  • to demonstrate perturbations of the immune responses by dysbiosis.

Connect with a study center

  • Service de Rhumatologie, Hôpital Ambroise Paré, APHP

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

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