Fibres Supplementation in Rheumatoid Arthritis (SUPER-FIBRES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Dietary Fiber Supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire DAIEN, MD-PhD; Phone Number: +33 467332319; Email: c-daien@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • UH Montpellier
    • Contact: Claire DAIEN; Email: c-daien@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General

Inclusion criteria:

• Aged 18 to 85
• Be affiliated to or beneficiary of a French social security scheme
• o No desire for pregnancy for the duration of the study (Effective contraception for women of reproductive age, for the duration of the study (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))

Exclusion criteria:

• Lack of written informed consent after a period of reflection
• Patient involved in other research or research for which the exclusion period has not ended
• Pregnant or nursing woman
• Type I or II diabetes
• Patient receiving more than 10 mg/d corticosteroids at time of inclusion
• Patient who received corticosteroid infusions in the month prior to randomization
• Unusual consumption (>50% higher than usual consumption) of dietary fibre in the last 72 hours (assessed by food questionnaire)

Patient with Rheumatoid polyarthritis

Inclusion criteria:

• Rheumatoid arthritis meeting ACR/EULAR 2010 criteria
• With moderate clinical activity: DAS28-CRP 3.2 and 5.1
• Patient receiving conventional background treatment at stable doses and should not be modified during 4-week follow-up

Exclusion criteria:

• Patient treated by targeted RA treatment in the year prior to inclusion
• Patient who received antibiotic therapy within 3 months prior to randomization

Control subjects

Inclusion criteria:

• Patient consulting in the rheumatology department for a mechanical pathology: osteoarthritis of the limbs or spine, osteoporosis, tendinopathy, fibromyalgia, algodystrophy or capsulitis.
• Matched to a gender and age PR topic 5 years

Exclusion criteria:

· Patient with autoimmune disease, infection or progressive cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhumatoid Arthritis; The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days	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)
Placebo Comparator: Control Subjects; The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Short-chain fatty acid (SCFA)	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the gut microbiota bacteria	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.	36 months
Description of immune cells (regulatory T and B cells, Th17)	Flow cytometric determination of immune cells	36 months
Evaluation of heart-rate variability.		36 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University of Sydney; Institut de Génétique Moléculaire de Montpellier
• Investigators: Principal Investigator: Claire DAIEN, CHU of MONTPELLIER

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; dietary fibre; gut-microbiota; SCFAs
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RECHMPL17_0397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No