Testing Lyophilized Fecal Microbiota against a placebo for ulcerative colitis
Official title: Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
Interventions
Lyophilized Fecal Microbiota Transplantation (LFMT)
LFMT by oral capsules
Placebo
Placebo capsules does not contain FMT
Canadian Sites (2)
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 years of age or older
- +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Established UC diagnosis through standard endoscopic and histologic criteria
- +Willing and able to comply with all required study procedures
- +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
Exclusion
- −Severe UC requiring hospitalization
- −Crohn's disease or indeterminate colitis
- −Irritable bowel syndrome
- −Intestinal infection within 4 weeks of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Evidence of toxic megacolon or gastrointestinal perforation on imaging
- −Planned colectomy
- −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
- −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
- −InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgement that enrolment is not in the best interest of the patient
- −Pregnancy or breastfeeding
- −Abdominal surgery within 60 days of enrollment
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
What is being given or done in this study: Lyophilized Fecal Microbiota Transplantation (LFMT), PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 85 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: At 8 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Steroid-free endoscopic remission — measured over At 8 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07401680 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Lyophilized Fecal Microbiota Transplantation (LFMT)Other
LFMT by oral capsules
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About PlaceboOther
Placebo capsules does not contain FMT
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At 8 weeks.
The study as a whole is currently expected to finish around 2028-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 85 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.