Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patient in remission or low disease activity by DAS28

• Consents to study

⁃ Fecal Donor Inclusion Criteria:

• A healthy donor who has a normal body mass index (BMI of 18.5-30) and who satisfies the following criteria will be selected from a pool of donors available in the Infectious Diseases clinic at St. Joseph's Hospital supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.

Locations
Other Locations
Canada
St. Joseph's Health Care London
RECRUITING
London
Contact Information
Primary
Lillian Barra, MD, MPH
Lillian.Barra@sjhc.london.on.ca
519-646-6100
Backup
Jeremy Burton, PhD
jeremy.burton@LawsonResearch.com
519-646-6100
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
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.
Placebo_comparator: Placebo
Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes.
Related Therapeutic Areas
Sponsors
Collaborators: St. Joseph's Health Care London
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov

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