Ulcerative ColitisPhase 1FRONTIER-UCNCT07401680
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
A Phase 1 study testing Lyophilized Fecal Microbiota Transplantation (LFMT) in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by University of Alberta at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases, Clostridioides Difficile Infection
- What is being tested?
- Lyophilized Fecal Microbiota Transplantation (LFMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2026to 1 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta, T2N-1N4
Humberto Jijon, MD, 403-220-3719, humberto.jijon2@ucalgary.ca
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2R3
Dina Kao, MD, FRCPC, 780-248-1342, dkao@ualberta.ca
About this study
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)
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.
Read the 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
- Add to current therapy (i.e., adjunct therapy) or
- Initiate or switch to a new advanced agent (i.e., co-administration)
The study will recruit 85 outpatients at 3 Canadian healthcare centres
- Being tested
- Lyophilized Fecal Microbiota Transplantation (LFMT), Placebo
- Keywords
- Fecal microbiota transplantation, FMT, Lyophilized fecal microbiota transplantation, LFMT
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized Fecal Microbiota Transplantation (LFMT)Other
LFMT by oral capsules
PlaceboOther
Placebo capsules does not contain FMT
| Study group | Role | What they receive |
|---|---|---|
| Adjunct therapy group (LFMT) | Experimental | 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 Receives: Other: Lyophilized Fecal Microbiota Transplantation (LFMT) |
| Adjunct therapy group (Placebo) | Placebo comparator | The placebo capsules will appear identical to LFMT capsules and same dosing will apply. Receives: Other: Placebo |
| Co-Administration therapy group (LFMT) | Experimental | 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 Receives: Other: Lyophilized Fecal Microbiota Transplantation (LFMT) |
| Co-Administration therapy group (Plcebo) | Placebo comparator | The placebo capsules will appear identical to LFMT capsules and same dosing will apply. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid-free endoscopic remission
Steroid-free endoscopic remission is defined as either
- Mayo endoscopy score (MES)= 0 OR
- MES=1 + FC <150 µg/g
Measured: At 8 weeks
Secondary outcomes (4)
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
Measured: up to week 24 or at time of withdrawal
Adverse outcomes
Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain
Measured: 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)
Measured: 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)
Measured: Baseline to 8 weeks and weeks 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind, placebo-controlled feasibility study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401680
- Sponsor's protocol ID
- Pro00160199
- Acronym
- FRONTIER-UC
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07401680
- Acronym / sponsor ID
- FRONTIER-UC / Pro00160199
- Keywords
- Fecal microbiota transplantation, FMT, Lyophilized fecal microbiota transplantation, LFMT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Add to current therapy (i.e., adjunct therapy) or
- Initiate or switch to a new advanced agent (i.e., co-administration)
The study will recruit 85 outpatients at 3 Canadian healthcare centres
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Multi-center, randomized, double-blind, placebo-controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Adjunct therapy group (LFMT) | Experimental | Other: Lyophilized Fecal Microbiota Transplantation (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 |
| Adjunct therapy group (Placebo) | Placebo comparator | Other: PlaceboThe placebo capsules will appear identical to LFMT capsules and same dosing will apply. |
| Co-Administration therapy group (LFMT) | Experimental | Other: Lyophilized Fecal Microbiota Transplantation (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 |
| Co-Administration therapy group (Plcebo) | Placebo comparator | Other: PlaceboThe placebo capsules will appear identical to LFMT capsules and same dosing will apply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized Fecal Microbiota Transplantation (LFMT)LFMT by oral capsules | Other | Adjunct therapy group (LFMT), Co-Administration therapy group (LFMT) |
| PlaceboPlacebo capsules does not contain FMT | Other | Adjunct therapy group (Placebo), Co-Administration therapy group (Plcebo) |
Primary outcome
Steroid-free endoscopic remission
Time frame: At 8 weeks
Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC <150 µg/g
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lyophilized Fecal Microbiota Transplantation (LFMT) in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Kao, MD,FRCPC (780-492-5257, dkao@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-free endoscopic remission (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.