Fibres Supplementation in Rheumatoid Arthritis (SUPER-FIBRES)
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dietary Fiber Supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs
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
Sites / Locations
- UH MontpellierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rhumatoid Arthritis
Control Subjects
Arm Description
The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Outcomes
Primary Outcome Measures
Evaluation of Short-chain fatty acid (SCFA)
Secondary Outcome Measures
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.
Description of immune cells (regulatory T and B cells, Th17)
Flow cytometric determination of immune cells
Evaluation of heart-rate variability.
Full Information
NCT ID
NCT04421313
First Posted
May 18, 2020
Last Updated
December 22, 2022
Sponsor
University Hospital, Montpellier
Collaborators
University of Sydney, Institut de Génétique Moléculaire de Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT04421313
Brief Title
Fibres Supplementation in Rheumatoid Arthritis
Acronym
SUPER-FIBRES
Official Title
Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University of Sydney, Institut de Génétique Moléculaire de Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rhumatoid Arthritis
Arm Type
Experimental
Arm Description
The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Arm Title
Control Subjects
Arm Type
Placebo Comparator
Arm Description
The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Intervention Type
Drug
Intervention Name(s)
Dietary Fiber Supplementation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Evaluation of Short-chain fatty acid (SCFA)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Description of the gut microbiota bacteria
Description
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.
Time Frame
36 months
Title
Description of immune cells (regulatory T and B cells, Th17)
Description
Flow cytometric determination of immune cells
Time Frame
36 months
Title
Evaluation of heart-rate variability.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire DAIEN, MD-PhD
Phone
467332319
Ext
+33
Email
c-daien@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire DAIEN
Organizational Affiliation
CHU of Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DAIEN
Email
c-daien@chu-montpellier.fr
12. IPD Sharing Statement
Learn more about this trial
Fibres Supplementation in Rheumatoid Arthritis
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