Recruiting
Phase 1

FMT

Sponsor:

University of Alberta

Code:

NCT07401680

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Clostridioides Difficile Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lyophilized Fecal Microbiota Transplantation (LFMT)

Placebo

Study Details

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

Study ID

NCT07401680

Start date

Mar 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

placebo comparator: Adjunct therapy group (Placebo)

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

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

placebo comparator: Co-Administration therapy group (Plcebo)

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

Interventions

Lyophilized Fecal Microbiota Transplantation (LFMT)

LFMT by oral capsules

Placebo

Placebo capsules does not contain FMT

Primary outcome measure

  • Steroid-free endoscopic remission [ Time Frame: At 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Fecal microbiota transplantation
  • FMT
  • Lyophilized fecal microbiota transplantation
  • LFMT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-04.