NCT04231110

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study of combination therapy using FMT and vedolizumab for induction of UC. The investigators hypothesize that a combination therapy approach which addresses immune trafficking and microbial manipulation simultaneously will lead to superior outcomes than those seen with single agent therapy.

Detailed description

This is a prospective pilot trial involving a single centre (McMaster University Medical Centre) recruiting patients from Hamilton, Ontario Canada and the surrounding regions, to evaluate efficacy and safety outcomes when using fecal microbiota transplantation once weekly for six weeks in UC patients who are initiated on vedolizumab. A lead in study will be conducted with the first five patients to ensure engraftment of FMT within the colon. Interim analysis will be conducted after these five patients to ensure engraftment within the colon. Data Safety and Monitoring Board will also be informed of the results after the first five patients, including any adverse events. Decision will be made based on these results whether to proceed with the prospective study using FMT weekly for six weeks, or whether to modify the dose/frequency of FMT treatment. As patients with previous biologic failure tend to have sub-optimal response to vedolizumab monotherapy, this pilot study will focus on recruitment of previous biologic failure patients.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbiota transplantation	Use of fecal microbiota transplantation enemas once weekly in patients who are initiating vedolizumab treatment

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2020-01-18
• Last updated: 2024-11-20

Locations

1 site across 1 country: Canada