LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
Phase 2 · Testing Lyophilized fecal microbiota (LFMT) · 1 site · University of Alberta
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Lyophilized fecal microbiota (LFMT) (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 18 years of age or older but less than 75 years of age
- Able to provide informed consent
- Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
Plus 6 more requirement(s). There are also 23 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2022-06-03.
- Main results expected around 2027-03-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT). (24 weeks)
In the researchers’ words
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | University of Alberta |
| Enrollment | 40 (estimated) |
| Start date | 2022-06-03 |
| Primary completion (est.) | 2027-03-31 |
| First posted | 2022-04-14 |
| Last updated | 2026-05-06 |
| Official title | A Dual-center, Double Blind, Randomized Placebo-controlled Pilot Trial of Concomitant Lyophilized Fecal Microbiota Transplantation (LFMT) and Biologic Therapy (Vedolizumab or Ustekinumab) for the Induction of Remission in Ulcerative Colitis (UC) |
| ClinicalTrials.gov ID | NCT05327790 |
Interventions
- Lyophilized fecal microbiota (LFMT) (Drug)
vedolizumab or ustekinumab + FMT vs placebo - Placebo (Other)
Placebo
Full eligibility criteria (from the record)
Inclusion Criteria:
1. 18 years of age or older but less than 75 years of age
2. Able to provide informed consent
3. Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
4. Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score >1 with disease that extends 15 cm or more from the anal verge
5. Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
* Biologic naive; OR
* Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules
6. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
7. Willing and able to comply with all required study procedures
Exclusion Criteria:
1. Severe UC requiring hospitalization
2. Indeterminate colitis
3. Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
4. Evidence of toxic megacolon or gastrointestinal perforation on imaging
5. Abdominal surgery within the past 60 days
* Neutropenia with absolute neutrophil count <0.5 x 109/L
* Peripheral white blood cell count > 35.0 x 109/L and fever (>38 degrees Celsius)
* Planned or actively taking another investigational product
* Uncontrolled medical conditions such as psychiatric disorders or substance abuse
* Severe underlying disease such that the patient is not expected to survive for at least 30 days
6. Pregnant or lactating
7. Unwilling to discontinue non-dietary probiotic
8. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
9. FMT within 3 months prior to enrollment
10. Use of the following medications:
1. rectal/topical therapy within 2 weeks of screening
2. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
3. tofacitinib within 4 weeks of screening
4. adalimumab or infliximab within 8 weeks of screening
5. vedolizumab within 8 weeks of screening
6. ustekinumab within 12 weeks of screening
7. prednisone > 30 mg/d
11. Investigator deems enrolment in the study is not in the best interest of the patientLocations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital | Edmonton, Alberta | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.