Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

NCT07401680 | Recruiting Phase 1 DMC

• 1 other identifier: Pro00160199
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases; Clostridioides Difficile Infection

Keywords

Fecal microbiota transplantation; FMT; Lyophilized fecal microbiota transplantation; LFMT

Outcome Measures

Primary Outcomes (1)

• Steroid-free endoscopic remission

  Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC \<150 µg/g

  At 8 weeks

Secondary Outcomes (4)

• Serious adverse events [SAE]

  up to week 24 or at time of withdrawal

• Adverse outcomes

  up to week 24 or upon withdrawal

• Quality of Life- sIBDQ

  Baseline to 8 weeks and 24 weeks

• Quality of Life- WPAI-IBD

  Baseline to 8 weeks and weeks 24

Other Outcomes (7)

• Recruitment rate

  Study start to the end of recruitment

• Consent rate

  Study start to the end of recruitment

• Symptom remission

  8 weeks and 24 weeks

Study Arms (4)

Adjunct therapy group (LFMT)

EXPERIMENTAL

Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks Maintenance phase: 1 capsule daily x 16 weeks

Other: Lyophilized Fecal Microbiota Transplantation (LFMT)

Adjunct therapy group (Placebo)

PLACEBO COMPARATOR

The placebo capsules will appear identical to LFMT capsules and same dosing will apply.

Other: Placebo

Co-Administration therapy group (LFMT)

EXPERIMENTAL

Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks Maintenance phase: 1 capsule daily x 16 weeks

Other: Lyophilized Fecal Microbiota Transplantation (LFMT)

Co-Administration therapy group (Plcebo)

PLACEBO COMPARATOR

The placebo capsules will appear identical to LFMT capsules and same dosing will apply.

Other: Placebo

Interventions

Lyophilized Fecal Microbiota Transplantation (LFMT) OTHER

LFMT by oral capsules

Adjunct therapy group (LFMT); Co-Administration therapy group (LFMT)

Placebo OTHER

Placebo capsules does not contain FMT

Adjunct therapy group (Placebo); Co-Administration therapy group (Plcebo)

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Able to provide informed consent
• Established UC diagnosis through standard endoscopic and histologic criteria
• Active UC
• 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
• Crohn's disease or indeterminate colitis
• Irritable bowel syndrome
• Intestinal infection within 4 weeks of enrollment
• Evidence of toxic megacolon or gastrointestinal perforation on imaging
• Planned colectomy
• Abdominal surgery within 60 days of enrollment
• Neutropenia with absolute neutrophil count \<0.5 x 109/L
• Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C)
• 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
• Pregnancy or breastfeeding
• Unwilling to discontinue non-dietary probiotic
• Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N-1N4, Canada

NOT YET RECRUITING

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Clostridium Infections

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Dina Kao, MD,FRCPC

CONTACT

780-233-6025; dkao@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized, double-blind, placebo-controlled feasibility study

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)