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FMT for Remission of Active Ulcerative Colitis in Adults

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Diseases

Status

Withdrawn

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

FMT oral

FMT enema

Placebo oral

Placebo enema

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, Fecal Microbiota transplant, FMT, Inflammatory bowel disease, IBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
Unwilling to discontinue probiotic (yogurt is allowed)
Severe underlying disease such that the patient is not expected to survive for at least 30 days.
Any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial

Sites / Locations

University of Alberta Hospital
Vancouver General Hospital
Royal Jubilee Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo oral & enema

LYO-FMT oral + placebo enema

LYO-FMT oral + LYO-FMT enema

Arm Description

twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema

Outcomes

Primary Outcome Measures

Remission of UC

achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1

Secondary Outcome Measures

Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]

Safety of LYO-FMT in patients with active UC as determined by absence of adverse events

UC disease progression

Determine progression of UC based on development of any of the following: Clinical flare of UC requiring hospitalization up to 3 months post-FMT Increase in dosages of current UC specific medications up to 3 months' post FMT Time to colectomy for UC flare up to 12 months' post FMT Time to death directly attributable to UC up to 5 years post FMT Improvement in clinical response defined by decrease in Partial Mayo score by ≥ 3 points from pre to post LYO-FMT. Improvement in patient-reported health related QoL using Valuation of Lost Productivity and (VOLP) and RAND VR12 measured at pre and at 5 weeks, 12 and 24 weeks following LYO-FMT and annually for 5 years Reduction in biologic inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) from pre to post LYO-FMT

Full Information

NCT ID

NCT04202211

First Posted

December 13, 2019

Last Updated

May 8, 2023

Sponsor

University of British Columbia

Collaborators

Crohn's and Colitis Canada

1. Study Identification

Unique Protocol Identification Number

NCT04202211

Brief Title

FMT for Remission of Active Ulcerative Colitis in Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Protocol changed substantially enough to warrant a separate submission

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

Crohn's and Colitis Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Inflammatory Bowel Diseases

Keywords

ulcerative colitis, Fecal Microbiota transplant, FMT, Inflammatory bowel disease, IBD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo oral & enema

Arm Type

Placebo Comparator

Arm Description

twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema

Arm Title

LYO-FMT oral + placebo enema

Arm Type

Active Comparator

Arm Description

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema

Arm Title

LYO-FMT oral + LYO-FMT enema

Arm Type

Active Comparator

Arm Description

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema

Intervention Type

Biological

Intervention Name(s)

FMT oral

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

FMT enema

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo oral

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo enema

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission of UC

Description

achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1

Time Frame

9 weeks following receipt of LYO-FMT

Secondary Outcome Measure Information:

Title

Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]

Description

Safety of LYO-FMT in patients with active UC as determined by absence of adverse events

Time Frame

up to 5 years post-FMT

Title

UC disease progression

Description

Time Frame

immediately after FMT (study) treatment period up to 5 years post-FMT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Unwilling to discontinue probiotic (yogurt is allowed) Severe underlying disease such that the patient is not expected to survive for at least 30 days. Any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ted Steiner, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Royal Jubilee Hospital

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 1J8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

FMT for Remission of Active Ulcerative Colitis in Adults

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