Fibres Supplementation in Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Dietary Fiber Supplementation

• Registration Number: NCT04421313
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-09-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Subjects	Dietary Fiber Supplementation	The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Rhumatoid Arthritis	Dietary Fiber Supplementation	The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days

Primary Outcome Measures

Name	Time	Method
Evaluation of Short-chain fatty acid (SCFA)	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France