NCT04853212

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

April 16, 2021

Last Update Submit

March 17, 2025

Conditions

SpondyloarthritisRuminococcus Gnavus

Keywords

SpondyloarthritisRuminococcus gnavusMicrobiotaDysbiosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Bacterial strain's abundance

    At the end of study, up to 2 years

  • Mucin-degradation of Ruminococcus gnavus

    At the end of study, up to 2 years

  • RNA sequencing analysis of biopsy

    At the end of study, up to 2 years

  • Interaction between bacteria and intestinal epithelial cells

    At the end of study, up to 2 years

  • Dysbiosis-induced immune perturbations

    At the end of study, up to 2 years

Study Arms (2)

SPA patient

ACTIVE COMPARATOR

Patients with SPA

Procedure: Biopsy

Subject without SPA

SHAM COMPARATOR

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

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Biopsy during recto-coloscopy

SPA patientSubject without SPA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

RECRUITING

Related 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.

    PMID: 28606969BACKGROUND

  • 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.

    PMID: 27223845BACKGROUND

MeSH Terms

Conditions

SpondylarthritisDysbiosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Maxime BREBAN, MD, PhD

    Service de Rhumatologie, Hôpital Ambroise Paré, APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime BREBAN, MD, PhD

CONTACT

+33 1 49 09 56 72maxime.breban@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

June 14, 2021

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)