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Completed

NCT Number: NCT01961310

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Lapeyronie, Montpellier, France

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Stool analysis

Biological

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

Primary outcomes

  1. The proportion of filamentous bacteria in the intestinal microbiota

    Time frame: Baseline (day 0)

Secondary outcomes

  1. The proportion of Proteus mirabilis in the intestinal microbiota

    Time frame: baseline (Day 0)

  2. The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota

    Time frame: baseline (Day 0)

  3. The number of species found in the intestinal microbiota

    Time frame: baseline (Day 0)

  4. Presence/absence of bacterial translocation

    Time frame: baseline (Day 0)

  5. Description of the ecology of intestinal microbiota

    Time frame: baseline (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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: MICROPOLY

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2013
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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