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The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04853212
Acronym
RUMINOSPA
Enrollment
100
Registered
2021-04-21
Start date
2021-06-14
Completion date
2026-05-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruminococcus Gnavus, Spondyloarthritis

Keywords

Spondyloarthritis, Ruminococcus gnavus, Microbiota, Dysbiosis

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.

Interventions

PROCEDUREBiopsy

Biopsy during recto-coloscopy

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Isolation and characterization of R. gnavusAt the end of study, up to 2 yearsIsolation and characterization of R. gnavus bacterium from intestinal biopsy.
Bacteria analysisAt the end of study, up to 2 yearsAnalysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.

Secondary

MeasureTime frameDescription
RNA sequencing analysis of biopsyAt the end of study, up to 2 yearsRNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
Bacterial strain's abundanceAt the end of study, up to 2 yearsCompare 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.
Dysbiosis-induced immune perturbationsAt the end of study, up to 2 yearsTo 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.
Interaction between bacteria and intestinal epithelial cellsAt the end of study, up to 2 yearsIn 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.
Mucin-degradation of Ruminococcus gnavusAt the end of study, up to 2 yearsStudy the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.

Countries

France

Contacts

Primary ContactMaxime BREBAN, MD, PhD
maxime.breban@aphp.fr+33 1 49 09 56 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026