NCT05327790RecruitingPhase 2
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
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)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Mar 2022
- Start date
- 3 Jun 2022
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of Alberta
- Diseases
- Ulcerative colitis
- NCT number
- NCT05327790
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 3 Jun 2022 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
- FMT within 3 months prior to enrollment
- Use of the following medications:
- rectal/topical therapy within 2 weeks of screening
- cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
- tofacitinib within 4 weeks of screening
- adalimumab or infliximab within 8 weeks of screening
- vedolizumab within 8 weeks of screening
- ustekinumab within 12 weeks of screening
- prednisone \> 30 mg/d
Other illness
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
Lab values
- 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
Other
- Severe UC requiring hospitalization
- Indeterminate colitis
- Pregnant or lactating
- Unwilling to discontinue non-dietary probiotic
- Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
- Investigator deems enrolment in the study is not in the best interest of the patient
Who the study is looking for
- 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
- 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
- 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
- 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
- Willing and able to comply with all required study procedures
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.