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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-08

Study Completion Date

2018-03-29

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.

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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).

Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Plasma analysis for bacterial translocation

Intervention Type BIOLOGICAL

1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.

Stool analysis

Intervention Type BIOLOGICAL

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

Plasma analysis for bacterial translocation

Intervention Type BIOLOGICAL

1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.

Stool analysis

Intervention Type BIOLOGICAL

DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.

Interventions

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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.

Intervention Type BIOLOGICAL

Stool analysis

DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes