drugset / Trial / NCT04421313

Fibres Supplementation in Rheumatoid Arthritis

NCT04421313

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

EvaluationDrugModalityDoseRoute
Subject Inulin Other / unclassified 12 g

Indications