The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis (RUMINOSPA)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Ruminococcus Gnavus; Spondyloarthritis

Treatments: Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04853212

2020-A03244-35 (Registry Identifier)

APHP210332

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

SPA patient

Active Comparator group

Description:

Patients with SPA

Treatment:

Procedure: Biopsy

Subject without SPA

Sham Comparator group

Description:

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

Treatment:

Procedure: Biopsy