Rheumatoid ArthritisSUPER-FIBRESNCT04421313
Fibres Supplementation in Rheumatoid Arthritis
A study testing Dietary Fiber Supplementation in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Dietary Fiber Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- Unusual consumption (>50% higher than usual consumption) of dietary fibre in the last 72 hours (assessed by food questionnaire)
- Patient with Rheumatoid polyarthritis
- 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
- Patient with autoimmune disease, infection or progressive cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier
Claire DAIEN, c-daien@chu-montpellier.fr
About this study
Official title: Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Dietary Fiber Supplementation
- Keywords
- Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fiber SupplementationDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Rhumatoid Arthritis | Experimental | The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days Receives: Drug: Dietary Fiber Supplementation |
| Control Subjects | Placebo comparator | The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days Receives: Drug: Dietary Fiber Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Short-chain fatty acid (SCFA)
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 36 months
Description of immune cells (regulatory T and B cells, Th17)
Flow cytometric determination of immune cells
Measured: 36 months
Evaluation of heart-rate variability.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Sep 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, Institut de Génétique Moléculaire de Montpellier
- Responsible party
- Sponsor
- Investigators
- Claire DAIEN, Principal investigator, CHU of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421313
- Sponsor's protocol ID
- RECHMPL17_0397
- Acronym
- SUPER-FIBRES
- Status last verified
- Dec 2022
- First submitted
- 18 May 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota
- ClinicalTrials.gov ID
- NCT04421313
- Acronym / sponsor ID
- SUPER-FIBRES / RECHMPL17_0397
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, dietary fibre, gut-microbiota, SCFAs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University of Sydney, Institut de Génétique Moléculaire de Montpellier
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhumatoid Arthritis | Experimental | Drug: Dietary Fiber SupplementationThe patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days |
| Control Subjects | Placebo comparator | Drug: Dietary Fiber SupplementationThe patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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))
- Rheumatoid arthritis meeting ACR/EULAR 2010 criteria
- With moderate clinical activity: DAS28-CRP 3.2 and 5.1
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fiber Supplementation12 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) | Drug | Control Subjects, Rhumatoid Arthritis |
Primary outcome
Evaluation of Short-chain fatty acid (SCFA)
Time frame: 36 months
3 secondary outcomes
Description of the gut microbiota bacteria
Time frame: 36 months
Description of immune cells (regulatory T and B cells, Th17)
Time frame: 36 months
Evaluation of heart-rate variability.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire DAIEN principal investigator
CHU of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber Supplementation in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire DAIEN, MD-PhD (467332319 ext. +33, c-daien@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Short-chain fatty acid (SCFA) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.