LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

NCT05327790 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00117170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

FMT; Microbiome

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).

  SAE of interest is defined as one of the following: * An infection attributable to FMT * Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy * Hospitalization due to UC or an infection attributable to FMT * Mortality due to UC or an infection attributable to FMT SAE of interest is defined as one of the following: * An infection attributable to FMT * Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy * Hospitalization due to UC or an infection attributable to FMT * Mortality due to UC or an infection attributable to FMT

  24 weeks

Secondary Outcomes (9)

• Proportion of participants in each group with adverse events during the study up to week 24, including nausea, vomiting, abdominal pain, worsening diarrhea, constipation or fevers

  24 weeks

• Proportion of participants who achieve clinical remission, defined as total Mayo score ≤ 2 with no individual subscore > 1, at week 8 and 24 in each group.

  24 weeks

• Proportion of participants who achieve clinical response

  24 weeks

• Proportion of participants who achieve symptom remission, defined as partial Mayo score < 2 with no individual subscore > 1, at week 8 and 24 in each group

  24 weeks

• Proportion of participants who achieve symptom response, defined as reduction in partial Mayo score ≥ 2 points from baseline and ≥ 30% from baseline and decrease in rectal bleeding score of ≥ 1point from baseline, at week 8 and 24 in each group

  24 weeks

Other Outcomes (4)

• Proportion of participants with Corticosteroid-free remission at week 8 and 24

  24 weeks

• Time to clinical remission, clinical response, symptom remission and symptom response in each group

  24 weeks

• Changes in stool microbiome at week 8 and 24 relative to baseline in each group

  24 weeks

Study Arms (4)

LFMT capsules + vedolizumab

EXPERIMENTAL

The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.

Drug: Lyophilized fecal microbiota (LFMT)

Placebo capsules + vedolizumab

PLACEBO COMPARATOR

The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.

Other: Placebo

LFMT capsules + ustekinumab

EXPERIMENTAL

The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.

Drug: Lyophilized fecal microbiota (LFMT)

Placebo capsules + ustekinumab

PLACEBO COMPARATOR

The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.

Other: Placebo

Interventions

Lyophilized fecal microbiota (LFMT) DRUG

vedolizumab or ustekinumab + FMT vs placebo

LFMT capsules + ustekinumab; LFMT capsules + vedolizumab

Placebo OTHER

Placebo

Placebo capsules + ustekinumab; Placebo capsules + vedolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain blinding, LFMT and placebo capsules will appear identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 14, 2022
• Study Start: June 3, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)