NCT04926103

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.

Conditions

• Ulcerative Colitis Flare

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2028-10-01
• Completion: 2029-05-01
• First posted: 2021-06-14
• Last updated: 2024-10-01

Locations

1 site across 1 country: Canada