MedTrace Logo

Fibres Supplementation in Rheumatoid Arthritis

NCT04421313 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-12-23

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Institut de Génétique Moléculaire de Montpellier

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Claire DAIEN · CHU of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421313 on ClinicalTrials.gov