Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs
Brief summary
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.
Interventions
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)
Sponsors
University of Sydney
Institut de Génétique Moléculaire de Montpellier
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion criteria: * Aged 18 to 85 * Be affiliated to or beneficiary of a French social security scheme * o No desire for pregnancy for the duration of the study (Effective contraception for women of reproductive age, for the duration of the study (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))
Exclusion criteria
* Lack of written informed consent after a period of reflection * Patient involved in other research or research for which the exclusion period has not ended * Pregnant or nursing woman * Type I or II diabetes * Patient receiving more than 10 mg/d corticosteroids at time of inclusion * Patient who received corticosteroid infusions in the month prior to randomization * Unusual consumption (\>50% higher than usual consumption) of dietary fibre in the last 72 hours (assessed by food questionnaire) Patient with Rheumatoid polyarthritis Inclusion criteria: * Rheumatoid arthritis meeting ACR/EULAR 2010 criteria * With moderate clinical activity: DAS28-CRP 3.2 and 5.1 * Patient receiving conventional background treatment at stable doses and should not be modified during 4-week follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Short-chain fatty acid (SCFA) | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the gut microbiota bacteria | 36 months | 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. |
| Description of immune cells (regulatory T and B cells, Th17) | 36 months | Flow cytometric determination of immune cells |
| Evaluation of heart-rate variability. | 36 months | — |
Countries
France
Contacts
Primary ContactClaire DAIEN, MD-PhD
Outcome results
None listed