LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta

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