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

NCT01961310 | Completed

• 2 other identifiers: AOIt/2012/JPL-012014-A01753-44
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthritis, Rheumatoid

Keywords

bacterial translocation; intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• The proportion of filamentous bacteria in the intestinal microbiota

  Baseline (day 0)

Secondary Outcomes (5)

• 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

  baseline (Day 0)

Study Arms (2)

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; Biological: Stool analysis

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; Biological: Stool analysis

Interventions

Plasma analysis for bacterial translocation 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.

Healthy voluteers; RA patients

Stool analysis BIOLOGICAL

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

Healthy voluteers; RA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Absence of digestive pathology
• RA diagnosis made within the past 12 months

You may not qualify if:

• 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
• RA was diagnosed more than 12 months ago
• Digestive pathology
• 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
• Does not have RA
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

Nîmes, 30908, France

Location

Related Publications (1)

• Dunyach-Remy C, Pouget C, Pers YM, Gaujoux-Viala C, Demattei C, Salipante F, Grenga L, Armengaud J, Lavigne JP, Jorgensen C. Participation of gut microbiota and bacterial translocation in chronic systemic inflammation in recently diagnosed rheumatoid arthritis patients. Curr Res Microb Sci. 2025 Feb 24;8:100366. doi: 10.1016/j.crmicr.2025.100366. eCollection 2025.

  PMID: 40123592 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Bacterial Translocation; Occult Blood

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Physiological Phenomena; Microbiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Catherine Dunyach-Rempy, PharmD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Jean Philippe Lavigne, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: March 8, 2016
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: November 21, 2025

Record last verified: 2020-07

Locations

FR (3)