The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Not Applicable

Recruiting

• Conditions: Spondyloarthritis; Ruminococcus Gnavus
• Interventions: Procedure: Biopsy

• Registration Number: NCT04853212
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Study Start: 2021-06-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 indication such 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 Criteria

• Subjects unable to understand the proposed study and/or sign a informed consent form;
• 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 the interpret of outcome;
• Refusal of subjects to participate to the study;
• Foreign patients under french AME scheme.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPA patient	Biopsy	Patients with SPA
Subject without SPA	Biopsy	Health subjects without SPA, planned to undergo a digestive endoscopy.

Primary Outcome Measures

Name	Time	Method
Isolation and characterization of R. gnavus	At the end of study, up to 2 years	Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Bacteria analysis	At the end of study, up to 2 years	Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.

Secondary Outcome Measures

Name	Time	Method
RNA sequencing analysis of biopsy	At the end of study, up to 2 years	RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
Mucin-degradation of Ruminococcus gnavus	At the end of study, up to 2 years	Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.
Interaction between bacteria and intestinal epithelial cells	At the end of study, up to 2 years	In order to study the interaction between bacteria and intestinal epithelial cells in culture (organoids).; Study the induction of several target genes as peptides anti-microbians, mucin or chemokines by RT-q-PCR.
Dysbiosis-induced immune perturbations	At the end of study, up to 2 years	To compare between 2 groups their reactivities of T cells from intestinal biopsy which contact with cells of exposed antigens in vitro, to R. gnavus stains or to other stains biopsied from control subjects.
Bacterial strain's abundance	At the end of study, up to 2 years	Compare the abundance by RT-q-PCR of bacterial strain (R. gnavus) between mucus biopsy sampling and faecal sampling, collected from PCR patients or control subjects respectively.

Trial Locations

Locations (1)

Service de Rhumatologie, Hôpital Ambroise Paré, APHP; 🇫🇷 Boulogne-Billancourt, France