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NCT Number: NCT04853212

The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy

Procedure

Biopsy during recto-coloscopy

Primary outcomes

  1. Isolation and characterization of R. gnavus

    Time frame: At the end of study, up to 2 years

    Isolation and characterization of R. gnavus bacterium from intestinal biopsy.

  2. Bacteria analysis

    Time frame: At the end of study, up to 2 years

    Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.

Secondary outcomes

  1. Bacterial strain's abundance

    Time frame: At the end of study, up to 2 years

    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.

  2. Mucin-degradation of Ruminococcus gnavus

    Time frame: At the end of study, up to 2 years

    Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.

  3. RNA sequencing analysis of biopsy

    Time frame: At the end of study, up to 2 years

    RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.

  4. Interaction between bacteria and intestinal epithelial cells

    Time frame: At the end of study, up to 2 years

    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.

  5. Dysbiosis-induced immune perturbations

    Time frame: At the end of study, up to 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime BREBAN, MD, PhD

CONTACT

[email protected]

+33 1 49 09 56 72

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: RUMINOSPA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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