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FMT for Remission of Active Ulcerative Colitis in Adults

NCT04202211 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-10

No results posted yet for this study

Summary

The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.

Conditions

Interventions

BIOLOGICAL

FMT oral

lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks

BIOLOGICAL

FMT enema

lyophilized FMT given via enema (1) twice weekly for total of 8 weeks

OTHER

Placebo oral

placebo given orally (10 capsules) twice weekly for total of 8 weeks

OTHER

Placebo enema

placebo given via enema (1) twice weekly for total of 8 weeks

Sponsors & Collaborators

  • Crohn's and Colitis Canada

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Ted Steiner, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2024-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202211 on ClinicalTrials.gov