NCT04421313

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

4.1 years

First QC Date

May 18, 2020

Last Update Submit

December 22, 2022

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisdietary fibregut-microbiotaSCFAs

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Short-chain fatty acid (SCFA)

    36 months

Secondary Outcomes (3)

  • Description of the gut microbiota bacteria

    36 months

  • Description of immune cells (regulatory T and B cells, Th17)

    36 months

  • Evaluation of heart-rate variability.

    36 months

Study Arms (2)

Rhumatoid Arthritis

EXPERIMENTAL

The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days

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

Drug: Dietary Fiber Supplementation

Interventions

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)

Control SubjectsRhumatoid Arthritis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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))

You may not qualify if:

  • Lack of written informed consent after a period of reflection
  • Pregnant or nursing woman
  • Type I or II diabetes
  • 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
  • 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 who received antibiotic therapy within 3 months prior to randomization
  • Control subjects
  • 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
  • · Patient with autoimmune disease, infection or progressive cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Claire DAIEN

    CHU of Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire DAIEN, MD-PhD

CONTACT

467332319c-daien@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 9, 2020

Study Start

September 2, 2020

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

FR(1)