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The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis (RUMINOSPA)

Primary Purpose

Spondyloarthritis, Ruminococcus Gnavus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spondyloarthritis focused on measuring Spondyloarthritis, Ruminococcus gnavus, Microbiota, Dysbiosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Service de Rhumatologie, Hôpital Ambroise Paré, APHPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

SPA patient

Subject without SPA

Arm Description

Patients with SPA

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

Outcomes

Primary Outcome Measures

Isolation and characterization of R. gnavus
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Bacteria analysis
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.

Secondary Outcome Measures

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.
Mucin-degradation of Ruminococcus gnavus
Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.
RNA sequencing analysis of biopsy
RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
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.
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.

Full Information

First Posted
April 16, 2021
Last Updated
March 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04853212
Brief Title
The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
Acronym
RUMINOSPA
Official Title
The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Ruminococcus Gnavus
Keywords
Spondyloarthritis, Ruminococcus gnavus, Microbiota, Dysbiosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPA patient
Arm Type
Active Comparator
Arm Description
Patients with SPA
Arm Title
Subject without SPA
Arm Type
Sham Comparator
Arm Description
Health subjects without SPA, planned to undergo a digestive endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Biopsy during recto-coloscopy
Primary Outcome Measure Information:
Title
Isolation and characterization of R. gnavus
Description
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Time Frame
At the end of study, up to 2 years
Title
Bacteria analysis
Description
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.
Time Frame
At the end of study, up to 2 years
Secondary Outcome Measure Information:
Title
Bacterial strain's abundance
Description
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.
Time Frame
At the end of study, up to 2 years
Title
Mucin-degradation of Ruminococcus gnavus
Description
Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.
Time Frame
At the end of study, up to 2 years
Title
RNA sequencing analysis of biopsy
Description
RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
Time Frame
At the end of study, up to 2 years
Title
Interaction between bacteria and intestinal epithelial cells
Description
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.
Time Frame
At the end of study, up to 2 years
Title
Dysbiosis-induced immune perturbations
Description
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.
Time Frame
At the end of study, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime BREBAN, MD, PhD
Phone
+33 1 49 09 56 72
Email
maxime.breban@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime BREBAN, MD, PhD
Organizational Affiliation
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28606969
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.
Results Reference
background
PubMed Identifier
27223845
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.
Results Reference
background

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The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

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