Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population (FRONTIER-UC)

A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Clostridioides Difficile Infection
• Intervention / Treatment: Other: Lyophilized Fecal Microbiota Transplantation (LFMT); Other: Placebo

Detailed Description

This is a randomized, double blind, placebo-controlled trial for UC patients with active disease.

Participants will be grouped into one of two categories

1. Add to current therapy (i.e., adjunct therapy)

   or

2. Initiate or switch to a new advanced agent (i.e., co-administration)

The study will recruit 85 outpatients at 3 Canadian healthcare centres

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dina Kao, MD,FRCPC; Phone Number: 780-233-6025; Email: dkao@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N-1N4
      • Not yet recruiting
      • University of Calgary
      • Contact: Humberto Jijon, MD; Phone Number: 403-220-3719; Email: humberto.jijon2@ucalgary.ca
    • Edmonton, Alberta, Canada, T6G2R3
      • Recruiting
      • University of Alberta
      • Contact: Dina Kao, MD, FRCPC; Phone Number: 780-233-6025; Email: dkao@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older
2. Able to provide informed consent
3. Established UC diagnosis through standard endoscopic and histologic criteria
4. Active UC
5. 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
6. Willing and able to comply with all required study procedures

Exclusion Criteria:

1. Severe UC requiring hospitalization
2. Crohn's disease or indeterminate colitis
3. Irritable bowel syndrome
4. Intestinal infection within 4 weeks of enrollment
5. Evidence of toxic megacolon or gastrointestinal perforation on imaging
6. Planned colectomy
7. Abdominal surgery within 60 days of enrollment
8. Neutropenia with absolute neutrophil count <0.5 x 109/L
9. Peripheral white blood cell count > 35.0 x 109/L and fever (>38C)
10. Planned or actively taking another investigational product
11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse
12. Severe underlying disease such that the patient is not expected to survive for at least 30 days
13. Pregnancy or breastfeeding
14. Unwilling to discontinue non-dietary probiotic
15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
16. FMT for any reason within 6 months of enrollment
17. Investigator's judgement that enrolment is not in the best interest of the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjunct therapy group (LFMT); 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); LFMT by oral capsules
Placebo Comparator: Adjunct therapy group (Placebo); The placebo capsules will appear identical to LFMT capsules and same dosing will apply.	Other: Placebo; Placebo capsules does not contain FMT
Experimental: Co-Administration therapy group (LFMT); 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); LFMT by oral capsules
Placebo Comparator: Co-Administration therapy group (Plcebo); The placebo capsules will appear identical to LFMT capsules and same dosing will apply.	Other: Placebo; Placebo capsules does not contain FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steroid-free endoscopic remission	Steroid-free endoscopic remission is defined as either; Mayo endoscopy score (MES)= 0 OR; MES=1 + FC <150 µg/g	At 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events [SAE]	SAEs including infections attributable to FMT, hospitalization due to UC exacerbation or complications related to FMT, or colectomy due to UC	up to week 24 or at time of withdrawal
Adverse outcomes	Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain	up to week 24 or upon withdrawal
Quality of Life- sIBDQ	Changes in health-related quality of life measures using the short IBD questionnaire (sIBDQ)	Baseline to 8 weeks and 24 weeks
Quality of Life- WPAI-IBD	Changes in health-related quality of life measures using the work productivity and activity impairment questionnaire (WPAI-IBD)	Baseline to 8 weeks and weeks 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Evaluation of rate of participant recruitment	Study start to the end of recruitment
Consent rate	Evaluation of rate of participant consent to participate	Study start to the end of recruitment
Symptom remission	Symptom remission, defined as partial Mayo score <2 with no individual subscore >1	8 weeks and 24 weeks
Symptom response	Symptom response, defined as reduction in partial Mayo score by >2 points from baseline and >30% from baseline and decrease in rectal bleeding score >1 point from baseline	At weeks 8 and 24
Endoscopic improvement	Endoscopic improvement, defined as a decrease of Mayo endoscopy score (MES) by at least 1 point	At week 8 and 24
UC therapy escalation	Avoidance of UC therapy escalation	At weeks 8 and 24
Stool microbial compositions	Changes in stool microbial compositions	between week 0 to 8 weeks and week 0 to 24 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: FMT; Fecal microbiota transplantation; Lyophilized fecal microbiota transplantation; LFMT
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Colitis; Colitis, Ulcerative; Clostridium Infections; Inflammatory Bowel Diseases
• Other Study ID Numbers: Pro00160199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No