Status:
UNKNOWN
Fibres Supplementation in Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
University of Sydney
Institut de Génétique Moléculaire de Montpellier
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-85 years
Phase:
NA
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. Secondar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04421313
Start Date
September 2 2020
End Date
October 1 2024
Last Update
December 23 2022
Active Locations (1)
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1
UH Montpellier
Montpellier, France