← Back to Search

Microbiota Restoration Therapy

LYO-FMT oral + LYO-FMT enema for Ulcerative Colitis

Phase 2

Waitlist Available

Led By Ted Steiner, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-fmt

Awards & highlights

Study Summary

This trial is being conducted to establish the safety and effectiveness of a fecal microbiota transplant for treating ulcerative colitis. The trial is double-blind and placebo-controlled, with three treatment arms. The primary outcome is remission of UC.

Eligible Conditions

Ulcerative Colitis
Inflammatory Bowel Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-fmt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-fmt

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-fmt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Remission of UC

Secondary outcome measures

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

UC disease progression

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: LYO-FMT oral + LYO-FMT enemaActive Control2 Interventions

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

Group II: LYO-FMT oral + placebo enemaActive Control2 Interventions

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

Group III: Placebo oral & enemaPlacebo Group2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vancouver Island Health AuthorityOTHER

16 Previous Clinical Trials

4,592 Total Patients Enrolled

Crohn's and Colitis CanadaOTHER

7 Previous Clinical Trials

1,332 Total Patients Enrolled

5 Trials studying Ulcerative Colitis

929 Patients Enrolled for Ulcerative Colitis

University of British ColumbiaLead Sponsor

1,412 Previous Clinical Trials

2,466,681 Total Patients Enrolled

7 Trials studying Ulcerative Colitis

1,970 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients who want to enroll in this trial?

"According to the latest information on clinicaltrials.gov, this particular trial is no longer recruiting patients. It was originally posted on February 1st, 2020 but the most recent update was December 16th, 2019. Although this study is not taking any more participants, there are 562 other trials which are currently open for recruitment."

Answered by AI

Are there any risks associated with this combination therapy of LYO-FMT oral and enema?

"LYO-FMT oral + LYO-FMT enema is currently being trialed in Phase 2, meaning that while there is evidence supporting its safety, there is none yet available for efficacy. Our team has rated this a 2 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FMT for Remission of Active Ulcerative Colitis in Adults

Theodore Steiner 2022. "FMT for Remission of Active Ulcerative Colitis in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04202211.