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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Biological: Plasma analysis for bacterial translocation
* Biological: Stool analysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients<br>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<br>* 1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.<br>Biological: Stool analysis<br>* DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.<br>|
| Healthy voluteers<br>This group is composed of 25 healthy volunteers. Intervention: Plasma analysis for bacterial translocation Intervention: Stool analysis | Biological: Plasma analysis for bacterial translocation<br>* 1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.<br>Biological: Stool analysis<br>* DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| The number of species found in the intestinal microbiota |  | baseline (Day 0) | 
| Presence/absence of bacterial translocation |  | baseline (Day 0) | 
| Description of the ecology of intestinal microbiota | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial translocation, intestinal microbiota