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

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

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

• Patients aged 18 or over

• Active UC defined as a Mayo score (7) \>3

• A Mayo endoscopic score (7) \>0

• Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Locations
Other Locations
Canada
Hamilton Health Sciences / McMaster University
RECRUITING
Hamilton
Contact Information
Primary
Melanie A Wolfe, CCRP
wolfe@hhsc.ca
9055212100
Backup
Aida Fernandes, MBA
fernaa19@mcmaster.ca
289-921-6483
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 200
Treatments
Experimental: Open label FMT therapy
FMT from a related or unrelated healthy donor screened for known communicable disease
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Hamilton Health Sciences Corporation

This content was sourced from clinicaltrials.gov

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