The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Spondyloarthritis Clinical Trial

— RUMINOSPA  

Official title:

The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853212
• Other study ID #: APHP210332
• Secondary ID: 2020-A03244-35
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maxime BREBAN, MD, PhD
• Phone: +33 1 49 09 56 72
• Email: maxime.breban[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Procedure:
• Biopsy
Biopsy during recto-coloscopy

Locations

Country	Name	City	State
France	Service de Rhumatologie, Hôpital Ambroise Paré, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolation and characterization of R. gnavus	Isolation and characterization of R. gnavus bacterium from intestinal biopsy.	At the end of study, up to 2 years
Primary	Bacteria analysis	Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.	At the end of study, up to 2 years
Secondary	Bacterial strain's abundance	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.	At the end of study, up to 2 years
Secondary	Mucin-degradation of Ruminococcus gnavus	Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.	At the end of study, up to 2 years
Secondary	RNA sequencing analysis of biopsy	RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.	At the end of study, up to 2 years
Secondary	Interaction between bacteria and intestinal epithelial cells	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.	At the end of study, up to 2 years
Secondary	Dysbiosis-induced immune perturbations	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.	At the end of study, up to 2 years