Lawson Health Research Institute
This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
Arthritis
Arthritis, Rheumatoid
Fecal Microbiota Transplantation
Fecal Microbial transplant
Placebo capsules
Not Applicable
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 |
Estimated Enrollment : | 30 participants |
Masking : | Double |
Masking Description : | Neither the participants or the investigator will know which treatment arms participants have been assigned to. This information can be obtained quickly from pharmacy if needed. |
Primary Purpose : | Treatment |
Official Title : | Fecal Microbial Transplantation for Rheumatoid Arthritis Trial |
Actual Study Start Date : | July 1, 2023 |
Estimated Primary Completion Date : | October 1, 2024 |
Estimated Study Completion Date : | April 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Fecal Microbial Transplant Participants will be administered 35-40 FMT capsules orally with water, for a total dose of 80-100g. This will only occur once and takes approximately 30 minutes. |
Drug: Fecal Microbial transplant |
Placebo Comparator: Placebo Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes. |
Other: Placebo capsules |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.