This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
This is a randomized double-blind placebo-controlled proof-of-concept trial. A total of 30 RA patients will be asked to join the study. They will be randomized to receive capsular FMT + standard of care or placebo + standard of care. There will be four study visits in total: Baseline, FMT administration, 6- and 12-week follow-up visits. Follow-up visits will consist of assessment by a rheumatologist, completion of surveys, and collection of biologic samples. Samples for the study are stool, urine and blood. Blood and fecal samples will be collected at baseline, 6 weeks and 12 weeks. Urine samples will be collected at baseline and 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
The placebo capsules will not contain FMT but will have the same appearance.
St. Joseph's Health Care London
London, Ontario, Canada
RECRUITINGChange 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
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: FMT treatment visit
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: 6 weeks post-treatment
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: 12 weeks post-treatment
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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.