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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St. Joseph's Health Care London
London, Ontario, Canada
Start Date
August 1, 2023
Primary Completion Date
August 1, 2025
Completion Date
April 1, 2026
Last Updated
August 21, 2024
30
ESTIMATED participants
Fecal Microbial transplant
DRUG
Placebo capsules
OTHER
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborators
NCT01422694
NCT06647069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07295509