SUPER-FIBRES: Fibres Supplementation in Rheumatoid Arthritis

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04421313

Collaborator

University of Sydney (Other), Institut de Génétique Moléculaire de Montpellier (Other)

Enrollment

Location

Arms

41.9

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Dietary Fiber Supplementation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 2, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Evaluation of Short-chain fatty acid (SCFA) [36 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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