|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
9 January 2023 |
|
Main ID: |
NCT04421313 |
|
Date of registration:
|
18/05/2020 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Fibres Supplementation in Rheumatoid Arthritis
SUPER-FIBRES |
|
Scientific title:
|
Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota |
|
Date of first enrolment:
|
September 2, 2020 |
|
Target sample size:
|
87 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04421313 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Claire DAIEN, MD-PhD |
|
Address:
|
|
|
Telephone:
|
467332319 |
|
Email:
|
c-daien@chu-montpellier.fr |
|
Affiliation:
|
|
|
|
Name:
|
Claire DAIEN |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU of Montpellier |
|
|
Name:
|
Claire DAIEN |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
c-daien@chu-montpellier.fr |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: Dietary Fiber Supplementation
|
|
Primary Outcome(s)
|
|
Evaluation of Short-chain fatty acid (SCFA)
[Time Frame: 36 months]
|
|
Secondary Outcome(s)
|
|
Description of immune cells (regulatory T and B cells, Th17)
[Time Frame: 36 months]
|
|
Evaluation of heart-rate variability.
[Time Frame: 36 months]
|
|
Description of the gut microbiota bacteria
[Time Frame: 36 months]
|
|
Secondary ID(s)
|
|
RECHMPL17_0397
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|