Clinical Trials Directory

Trials / Completed

CompletedNCT01961310

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

Status
Completed
Phase
Study type
Observational
Enrollment
55 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlasma analysis for bacterial translocation1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.
BIOLOGICALStool analysisDNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.

Timeline

Start date
2016-03-08
Primary completion
2018-03-29
Completion
2018-03-29
First posted
2013-10-11
Last updated
2025-11-21

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01961310. Inclusion in this directory is not an endorsement.