Comparing LFMT and placebo for treating 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)
This study is testing whether a new treatment made from processed stool can help people with active ulcerative colitis feel better when they start taking certain medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | vedolizumab, ustekinumab, adalimumab, infliximab, tofacitinib, prednisone |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05327790 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the safety and efficacy of lyophilized fecal microbiota (LFMT) compared to a placebo in patients with active ulcerative colitis who are starting treatment with biologics vedolizumab or ustekinumab. The study is a dual-center, randomized, double-blind, placebo-controlled design, enrolling 40 outpatients across two Canadian healthcare centers. Participants will be monitored for their response to treatment and any adverse effects over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with active ulcerative colitis who are initiating biologic therapy.
Not a fit: Patients with severe ulcerative colitis requiring hospitalization or those with indeterminate colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients with ulcerative colitis, potentially improving their treatment outcomes.
How similar studies have performed: Other studies have explored fecal microbiota transplants in various conditions, but this specific approach in ulcerative colitis is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 patient
Where this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.