drugset / Trial / NCT04421313
Fibres Supplementation in Rheumatoid Arthritis
Unknown
87 enrolled
University Hospital, Montpellier
Institut de Génétique Moléculaire de Montpellier · collabUniversity of Sydney · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2020-09-02
- Primary completion
- 2024-10
- Completion
- 2024-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inulin | Other / unclassified | 12 g | — |