RecruitingPhase 2NCT05327790

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)

Sponsor

University of Alberta

Enrollment

40 participants

Start Date

Jun 3, 2022

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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

Exclusion Criteria23

Severe UC requiring hospitalization
Indeterminate colitis
Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
Evidence of toxic megacolon or gastrointestinal perforation on imaging
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
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
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
Investigator deems enrolment in the study is not in the best interest of the patient