The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2026-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Spondyloarthritis Ruminococcus Gnavus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SPA patient

Patients with SPA

Group Type ACTIVE_COMPARATOR

Biopsy

Intervention Type PROCEDURE

Biopsy during recto-coloscopy

Subject without SPA

Health subjects without SPA, planned to undergo a digestive endoscopy.

Group Type SHAM_COMPARATOR

Biopsy

Intervention Type PROCEDURE

Biopsy during recto-coloscopy

Interventions

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Biopsy

Biopsy during recto-coloscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes