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Recruiting NCT07401680

Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

Phase I Interventional Ulcerative Colitis Inflammatory Bowel Diseases Clostridioides Difficile Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lyophilized Fecal Microbiota Transplantation (LFMT), Placebo.
Who it may be relevant to
Registry conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Clostridioides Difficile Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Interventions

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

Primary outcome measures

  • Steroid-free endoscopic remission [Time frame: At 8 weeks]
Secondary outcome measures (4)
  • Serious adverse events [SAE] [Time frame: up to week 24 or at time of withdrawal]
  • Adverse outcomes [Time frame: up to week 24 or upon withdrawal]
  • Quality of Life- sIBDQ [Time frame: Baseline to 8 weeks and 24 weeks]
  • Quality of Life- WPAI-IBD [Time frame: Baseline to 8 weeks and weeks 24]

Eligibility criteria

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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
  • FMT for any reason within 6 months of enrollment
  • Investigator's judgement that enrolment is not in the best interest of the patient

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • University of Calgary — Calgary
  • University of Alberta — Edmonton

Identifiers

NCT: NCT07401680 · Pro00160199

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗