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

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Biological: Plasma analysis for bacterial translocation; Biological: Stool analysis

• Registration Number: NCT01961310
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Study Start: 2016-03-08
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy voluteers	Plasma analysis for bacterial translocation	This group is composed of 25 healthy volunteers. * Intervention: Plasma analysis for bacterial translocation * Intervention: Stool analysis
RA patients	Plasma analysis for bacterial translocation	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
RA patients	Stool analysis	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
Healthy voluteers	Stool analysis	This group is composed of 25 healthy volunteers. * Intervention: Plasma analysis for bacterial translocation * Intervention: Stool analysis

Primary Outcome Measures

Name	Time	Method
The proportion of filamentous bacteria in the intestinal microbiota	Baseline (day 0)

Secondary Outcome Measures

Name	Time	Method
Presence/absence of bacterial translocation	baseline (Day 0)
The number of species found in the intestinal microbiota	baseline (Day 0)
Description of the ecology of intestinal microbiota	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.
The proportion of Proteus mirabilis in the intestinal microbiota	baseline (Day 0)
The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota	baseline (Day 0)

Trial Locations

Locations (3)

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine; 🇫🇷 Nîmes Cedex 2, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France