Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis
NCT04231110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2024-11-20
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.
Conditions
Interventions
- BIOLOGICAL
-
Fecal microbiota transplantation
Use of fecal microbiota transplantation enemas once weekly in patients who are initiating vedolizumab treatment
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2024-11-18
- Completion
- 2024-11-18
Countries
- Canada
Study Locations
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