Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

Conditions

• Clostridioides Difficile Infection
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lyophilized Fecal Microbiota Transplantation (LFMT) — OTHER
  LFMT by oral capsules
• Placebo — OTHER
  Placebo capsules does not contain FMT

Study Details

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.

Key Dates

First listed

Feb 10, 2026

Start date

Mar 1, 2026

Status verified

Jun 2026

Primary completion

Mar 1, 2028

Completion

Dec 1, 2028

Study Design

Enrollment

85 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Dina Kao, MD,FRCPC
  780-492-5257
  [email protected]

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