Fibres Supplementation in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Dietary Fiber Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhumatoid Arthritis<br>The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days | Drug: Dietary Fiber Supplementation<br>* 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)<br>|
| Placebo Comparator: Control Subjects<br>The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days | Drug: Dietary Fiber Supplementation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs