Fibres Supplementation in Rheumatoid Arthritis

NCT ID: NCT04421313

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2024-10-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rhumatoid Arthritis

The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days

Group Type: EXPERIMENTAL

Dietary Fiber Supplementation

Intervention Type: DRUG

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)

Control Subjects

The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days

Group Type: PLACEBO_COMPARATOR

Dietary Fiber Supplementation

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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))

• 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

• 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

• 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

• 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

· Patient with autoimmune disease, infection or progressive cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

Institut de Génétique Moléculaire de Montpellier

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire DAIEN

Role: PRINCIPAL_INVESTIGATOR

CHU of Montpellier

Locations

UH Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Claire DAIEN, MD-PhD

Role: CONTACT

c-daien@chu-montpellier.fr

467332319 ext. +33

Facility Contacts

Claire DAIEN

Role: primary

c-daien@chu-montpellier.fr

Other Identifiers

RECHMPL17_0397

Identifier Type: -

Identifier Source: org_study_id