Loading clinical trials...

FMT for Remission of Active Ulcerative Colitis in Adults | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

FMT for Remission of Active Ulcerative Colitis in Adults

A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis

NCT04202211•University of British Columbia

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to provide informed consent.
•Willing and able to comply with all the required trial procedures
•Active ulcerative colitis as defined by Mayo score \> 3 AND Mayo endoscopic sub-score \> 1 (within 30 days before enrollment, or at baseline)

Exclusion Criteria

•Planned or actively taking another investigational product
•Abdominal surgery within the past 60 days
•Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L at - Evidence of toxic megacolon or gastrointestinal perforation on imaging
•Peripheral white blood cell count \> 35.0 x 109/L at enrollment AND temperature \> 38.0oC
•Active infectious diarrhea at the time of enrolment
•Increase in medical therapy for UC within 3 months of enrollment. Continued treatment with stable dose of 5-ASA, azathioprine, 6-mercaptopurine, cyclosporine, prednisone and/or anti- TNF agents for at least 3 months of is allowed
•Severe UC requiring hospitalization at the time of enrolment
•Pregnant or lactating
•History of anaphylaxis to any food
•Requiring oral and/or intravenous systemic antibiotic therapy at the time of study enrolment
+3 more criteria

Locations (3)

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Key Dates

Start Date

March 1, 2022

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2028

Last Updated

May 10, 2023

Conditions

Ulcerative ColitisInflammatory Bowel Diseases

Interventions

FMT oral

BIOLOGICAL

FMT enema

BIOLOGICAL

Placebo oral

OTHER

Placebo enema

OTHER

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITING

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

FMT for Remission of Active Ulcerative Colitis in Adults

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)