Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
87 participants
INTERVENTIONAL
2020-09-02
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rhumatoid Arthritis
The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Dietary Fiber Supplementation
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)
Control Subjects
The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
Dietary Fiber Supplementation
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dietary Fiber Supplementation
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sydney
OTHER
Institut de Génétique Moléculaire de Montpellier
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claire DAIEN
Role: PRINCIPAL_INVESTIGATOR
CHU of Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UH Montpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Claire DAIEN
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RECHMPL17_0397
Identifier Type: -
Identifier Source: org_study_id