Arthritis, Rheumatoid Clinical Trial
— MICROPOLYOfficial title:
Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis
Verified date | July 2020 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 29, 2018 |
Est. primary completion date | March 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | |
France | Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine | Nîmes Cedex 2 | |
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of filamentous bacteria in the intestinal microbiota | Baseline (day 0) | ||
Secondary | The proportion of Proteus mirabilis in the intestinal microbiota | baseline (Day 0) | ||
Secondary | The proportion of species producing peptidyl arginine desaminase (PAD) in the intestinal microbiota | baseline (Day 0) | ||
Secondary | The number of species found in the intestinal microbiota | baseline (Day 0) | ||
Secondary | Presence/absence of bacterial translocation | baseline (Day 0) | ||
Secondary | 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) |
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