NCT04421313

Fibres Supplementation in Rheumatoid Arthritis

Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Dietary Fiber Supplementation	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)

Timeline

• Start date: 2020-09-02
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-06-09
• Last updated: 2022-12-23

Locations

1 site across 1 country: France