Clinical trial NCT04421313: Fibres Supplementation in Rheumatoid Arthritis
Official title: Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
dietary fibre
gut-microbiota
SCFAs
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: Institut de Génétique Moléculaire de Montpellier
First posted: 2020-06-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Short-chain fatty acid (SCFA)
timeFrame: 36 months
Secondary outcomes:
measure: Description of the gut microbiota bacteria
timeFrame: 36 months
measure: Description of immune cells (regulatory T and B cells, Th17)
timeFrame: 36 months
measure: Evaluation of heart-rate variability.
timeFrame: 36 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: CHU of Montpellier
name: Claire DAIEN
role: PRINCIPAL_INVESTIGATOR
References: