Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

ConditionsArthritis Arthritis, Rheumatoid Fecal Microbiota Transplantation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-years old or older

RA diagnosis by ACR/EULAR criteria [26]

Positive for the RA-associated antibodies, anti-citrullinated protein/peptide antibodies (ACPA) and/or rheumatoid factor (RF)

Stable RA therapy > 6 months

Disqualifiers

Pregnant or breastfeeding

Current or recent [in the last 60 days] exposure to high dose oral (>30 mg of prednisone daily or equivalent), IV corticosteroids, biologic therapies or JAKi.

Patients who require inhaled steroids or local steroid injections are not excluded from the study

Has a diagnosis of immunodeficiency (HIV, transplantation, or autoimmune disease other than RA requiring immunosuppressive therapies), or currently receiving systemic steroid therapy (>10 mg prednisone daily or equivalent)

Trial design

Design model

Parallel

Treatments tested in this trial

Fecal Microbial transplant
Drug
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
Placebo capsules
Other intervention
The placebo capsules will not contain FMT but will have the same appearance.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Fecal Microbial TransplantExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Intestinal Permeability

A blood sample will be collected for bacterial DNA analysis.

Time frame

Baseline and 6 weeks

Change in Intestinal Permeability

A urine sample will be collected to measure the lactulose to mannitol ratio.

Time frame

Baseline and 6 weeks

Change in RA-associated autoantibodies

A blood sample will be collected to measure RA-associated autoantibodies.

Time frame

Baseline, 6 weeks and 12 weeks

Adverse Events

Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.

Time frame

Baseline

Secondary outcomes

Change in Fecal Microbial Composition

Stool samples will be collected to determine fecal microbial composition using 16S-RNA sequencing.

Time frame

Baseline, 6 weeks and 12 weeks

Change in C-Reactive Protein

Blood sample will be collected to measure CRP levels.

Time frame

Baseline, 6 weeks and 12 weeks.

Other outcomes

Pain Visual Analog Scale

Change in pain will be measured using a visual analog scale.

Time frame

Baseline, 6 weeks and 12 weeks

Fatigue

Change in fatigue will be measured with a visual analog scale.

Time frame

Baseline, 6 weeks and 12 weeks

Sleep

Change in sleep will be measured with a visual analog scale.

Time frame

Baseline, 6 weeks and 12 weeks

Change in RA disease activity

RA disease activity will be measured using the disease activity score-28 (DAS28).

Time frame

Baseline, 6 weeks and 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead sponsor

St. Joseph's Health Care London

Collaborator

Source ClinicalTrials.gov

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