NCT05327790 LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
| NCT ID | NCT05327790 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-06-03 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2022-06-03 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Eligibility 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
Frequently Asked Questions
Who can join the NCT05327790 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05327790 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05327790 currently recruiting?
Yes, NCT05327790 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Alberta to inquire about joining.
Where is the NCT05327790 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05327790 clinical trial?
NCT05327790 is sponsored by University of Alberta. The trial plans to enroll 40 participants.
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