Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sydney | OTHER |
| Institut de Génétique Moléculaire de Montpellier | OTHER |
Not provided
Not provided
Not provided
Not provided
Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo.
Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability.
Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis).
Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhumatoid Arthritis | Experimental | The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days |
|
| Control Subjects | Placebo Comparator | The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Fiber Supplementation | Drug | 12 g of inulin or of maltodextrin in powder, to dilute in water once daily, during 1 month. Given in pre-weighted pots (one pot per day, similar color and aspect) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Short-chain fatty acid (SCFA) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the gut microbiota bacteria | Amplification of the V1-V3 bacterial region targeting 16S bacterial ribosomal RNA and sequencing by Mi-sequencer will be performed. Then, a bioinformatics analysis will be done using the QIIME software and the composition of the intestinal flora will be analyzed. | 36 months |
Not provided
General
Inclusion criteria:
Exclusion criteria:
Patient with Rheumatoid polyarthritis
Inclusion criteria:
Exclusion criteria:
Control subjects
Inclusion criteria:
Exclusion criteria:
· Patient with autoimmune disease, infection or progressive cancer
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire DAIEN, MD-PhD | Contact | 467332319 | +33 | c-daien@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire DAIEN | CHU of Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Montpellier | Recruiting | Montpellier | France |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Description of immune cells (regulatory T and B cells, Th17) |
Flow cytometric determination of immune cells |
| 36 months |
| Evaluation of heart-rate variability. | 36 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |