Clinical trial NCT04853212: The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
Official title: The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondyloarthritis
Ruminococcus Gnavus
Keywords: Spondyloarthritis
Ruminococcus gnavus
Microbiota
Dysbiosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Isolation and characterization of R. gnavus
timeFrame: At the end of study, up to 2 years
measure: Bacteria analysis
timeFrame: At the end of study, up to 2 years
Secondary outcomes:
measure: Bacterial strain's abundance
timeFrame: At the end of study, up to 2 years
measure: Mucin-degradation of Ruminococcus gnavus
timeFrame: At the end of study, up to 2 years
measure: RNA sequencing analysis of biopsy
timeFrame: At the end of study, up to 2 years
measure: Interaction between bacteria and intestinal epithelial cells
timeFrame: At the end of study, up to 2 years
measure: Dysbiosis-induced immune perturbations
timeFrame: At the end of study, up to 2 years
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Study officials:
affiliation: Service de Rhumatologie, Hôpital Ambroise Paré, APHP
name: Maxime BREBAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
citation: Crost EH, Tailford LE, Monestier M, Swarbreck D, Henrissat B, Crossman LC, Juge N. The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases. Gut Microbes. 2016 Jul 3;7(4):302-312. doi: 10.1080/19490976.2016.1186334. Epub 2016 May 25.