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RECRUITING
NCT04926103
NA

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

Summary

The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.

Official title: Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-07-01

Completion Date

2029-05-01

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

OTHER

Fecal Microbiota transplant (FMT)

Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years

Locations (1)

Hamilton Health Sciences / McMaster University

Hamilton, Ontario, Canada