Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01961310
Acronym
MICROPOLY
Enrollment
55
Registered
2013-10-11
Start date
2016-03-08
Completion date
2018-03-29
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

bacterial translocation, intestinal microbiota

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).

Interventions

BIOLOGICALPlasma 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.

BIOLOGICALStool analysis

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The proportion of filamentous bacteria in the intestinal microbiotaBaseline (day 0)

Secondary

MeasureTime frameDescription
The proportion of Proteus mirabilis in the intestinal microbiotabaseline (Day 0)
The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiotabaseline (Day 0)
The number of species found in the intestinal microbiotabaseline (Day 0)
Presence/absence of bacterial translocationbaseline (Day 0)
Description of the ecology of intestinal microbiotabaseline (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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026