Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis (MICROPOLY)

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.

The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The secondary objectives of this study are :

  • A. To compare between the two groups :
  • a. The proportion of Proteus mirabilis in the intestinal microbiota;
  • b . The proportion of species producing peptidyl arginine deaminase (PAD ) in the intestinal microbiota;
  • c . The number of species found in the intestinal microbiota.
  • B. To evaluate bacterial translocation (from the digestive tract) in newly diagnosed RA patients with and healthy volunteers without RA. (Bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. LPS teichoïc acid) cross the intestinal barrier and reach the bloodstream.).
  • C. To describe the ecology of the intestinal microbiota of newly diagnosed RA patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with RA than in individuals without RA).

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Lapeyronie
      • Nîmes, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Nîmes, France, 30908
        • Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 50 adult subjects will be included: 25 with newly diagnosed RA (<12 months) based on the American College of Rheumatology criteria, and 25 healthy volunteers without RA.

Description

Inclusion Criteria for RA patients:

  • The patient was correctly informed
  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • No antibiotic treatments within the 30 days preceding inclusion
  • Absence of digestive pathology
  • RA diagnosis made within the past 12 months

Exclusion Criteria for RA patients:

  • The patient has participated in another study within the past 3 months
  • The patient is under judicial protection, or any kind of guardianship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has taken antibiotics in the 30 days preceding inclusion
  • RA was diagnosed more than 12 months ago
  • Digestive pathology

Inclusion Criteria for healthy volunteers (HV):

  • The HV was correctly informed
  • The HV must have given his/her informed and signed consent
  • The HV must be insured or beneficiary of a health insurance plan
  • Absence of digestive pathology
  • No antibiotic treatments within the 30 days preceding inclusion
  • Does not have RA

Exclusion Criteria for HVs:

  • The HV has participated in another study within the past 3 months
  • The HV is under judicial protection, or any kind of guardianship
  • The HV refuses to sign the consent
  • It is impossible to correctly inform the HV
  • The HV is pregnant, parturient, or breastfeeding
  • The HV has taken antibiotics in the 30 days preceding inclusion
  • Digestive pathology
  • Joint pathology of any kind (including inflammatory pathologies)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA patients

This group is composed of 25 patients with RA. The diagnosis of RA is based upon the American College of Rheumatology criteria.

  • Intervention: Plasma analysis for bacterial translocation
  • Intervention: Stool analysis
Biological: Plasma analysis for bacterial translocation
1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.
Biological: Stool analysis
DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.
Healthy voluteers

This group is composed of 25 healthy volunteers.

  • Intervention: Plasma analysis for bacterial translocation
  • Intervention: Stool analysis
Biological: Plasma analysis for bacterial translocation
1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.
Biological: Stool analysis
DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of filamentous bacteria in the intestinal microbiota
Time Frame: Baseline (day 0)
Baseline (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of Proteus mirabilis in the intestinal microbiota
Time Frame: baseline (Day 0)
baseline (Day 0)
The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota
Time Frame: baseline (Day 0)
baseline (Day 0)
The number of species found in the intestinal microbiota
Time Frame: baseline (Day 0)
baseline (Day 0)
Presence/absence of bacterial translocation
Time Frame: baseline (Day 0)
baseline (Day 0)
Description of the ecology of intestinal microbiota
Time Frame: baseline (Day 0)
Diversity indices according to species and/or functional groups. The general goal is to provide a description of the functional differences between groups.
baseline (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Catherine Dunyach-Rempy, PharmD, PhD, Centre Hospitalier Universitaire de Nîmes
  • Principal Investigator: Jean Philippe Lavigne, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2016

Primary Completion (Actual)

March 29, 2018

Study Completion (Actual)

March 29, 2018

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimated)

October 11, 2013

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOIt/2012/JPL-01
  • 2014-A01753-44 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on Plasma analysis for bacterial translocation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe