NCT05790356

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Arthritis
• Arthritis, Rheumatoid
• Fecal Microbiota Transplantation

Interventions

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

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2026-04-01
• First posted: 2023-03-30
• Last updated: 2024-08-21

Locations

1 site across 1 country: Canada