Fibres Supplementation in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— SUPER-FIBRES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04421313
• Other study ID #: RECHMPL17_0397
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Montpellier
• Contact: Claire DAIEN, MD-PhD
• Phone: 467332319
• Email: c-daien[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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)

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut de Génétique Moléculaire de Montpellier, University of Sydney

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Short-chain fatty acid (SCFA)		36 months
Secondary	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
Secondary	Description of immune cells (regulatory T and B cells, Th17)	Flow cytometric determination of immune cells	36 months
Secondary	Evaluation of heart-rate variability.		36 months