Ulcerative ColitisPhase 2NCT05327790
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
A Phase 2 study testing Lyophilized fecal microbiota (LFMT) in people with Ulcerative Colitis, run by University of Alberta at 1 site in Canada.
Trial summary
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Lyophilized fecal microbiota (LFMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2022to 31 Mar 2027
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older but less than 75 years of age
- Able to provide informed consent
- Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
- Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score >1 with disease that extends 15 cm or more from the anal verge
- Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
- Biologic naive; OR
Show all 9Show fewer
- Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules
- 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
- Indeterminate colitis
- Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Abdominal surgery within the past 60 days
- Neutropenia with absolute neutrophil count <0.5 x 109/L
Show all 23Show fewer
- Peripheral white blood cell count > 35.0 x 109/L and fever (>38 degrees Celsius)
- 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
- Pregnant or lactating
- Unwilling to discontinue non-dietary probiotic
- Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
- FMT within 3 months prior to enrollment
- Use of the following medications:
- rectal/topical therapy within 2 weeks of screening
- cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
- tofacitinib within 4 weeks of screening
- adalimumab or infliximab within 8 weeks of screening
- vedolizumab within 8 weeks of screening
- ustekinumab within 12 weeks of screening
- prednisone > 30 mg/d
- Investigator deems enrolment in the study is not in the best interest of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
Dina Kao, MD, 780 492 8307, dkao@ualberta.ca
About this study
Official title: A Dual-center, Double Blind, Randomized Placebo-controlled Pilot Trial of Concomitant Lyophilized Fecal Microbiota Transplantation (LFMT) and Biologic Therapy (Vedolizumab or Ustekinumab) for the Induction of Remission in Ulcerative Colitis (UC)
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Read the detailed description
This is dual-center, randomized, double-blind, placebo-controlled pilot trial for UC patients with active disease who are being initiated on treatment with vedolizumab or ustekinumab.
The study will recruit 40 outpatients at 2 Canadian healthcare centres at the University of Alberta Hospital (University of Alberta), and the University of Manitoba.
- Conditions
- Ulcerative Colitis
- Being tested
- Lyophilized fecal microbiota (LFMT), Placebo
- Keywords
- FMT, Microbiome
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized fecal microbiota (LFMT)Drug
vedolizumab or ustekinumab + FMT vs placebo
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LFMT capsules + vedolizumab | Experimental | The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants. Receives: Drug: Lyophilized fecal microbiota (LFMT) |
| Placebo capsules + vedolizumab | Placebo comparator | The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules. Receives: Other: Placebo |
| LFMT capsules + ustekinumab | Experimental | The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants. Receives: Drug: Lyophilized fecal microbiota (LFMT) |
| Placebo capsules + ustekinumab | Placebo comparator | The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).
SAE of interest is defined as one of the following:
- An infection attributable to FMT
- Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy
- Hospitalization due to UC or an infection attributable to FMT
- Mortality due to UC or an infection attributable to FMT
SAE of interest is defined as one of the following:
- An infection attributable to FMT
- Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy
- Hospitalization due to UC or an infection attributable to FMT
- Mortality due to UC or an infection attributable to FMT
Measured: 24 weeks
Secondary outcomes (9)
Proportion of participants in each group with adverse events during the study up to week 24, including nausea, vomiting, abdominal pain, worsening diarrhea, constipation or fevers
Measured: 24 weeks
Proportion of participants who achieve clinical remission, defined as total Mayo score ≤ 2 with no individual subscore > 1, at week 8 and 24 in each group.
Measured: 24 weeks
Proportion of participants who achieve clinical response
Defined as a reduction in the Mayo clinic score of ≥ 3 points and/ or ≥ 30% from baseline, with a decrease in the rectal bleeding subscore of ≥ 1 point or a subscore ≤ 1 at week 8 and 24 in each group
Measured: 24 weeks
Proportion of participants who achieve symptom remission, defined as partial Mayo score < 2 with no individual subscore > 1, at week 8 and 24 in each group
Measured: 24 weeks
Proportion of participants who achieve symptom response, defined as reduction in partial Mayo score ≥ 2 points from baseline and ≥ 30% from baseline and decrease in rectal bleeding score of ≥ 1point from baseline, at week 8 and 24 in each group
Measured: 24 weeks
Proportion of participants who achieve endoscopic improvement, defined as Mayo endoscopic subscore ≤1, at week 8 and 24 in each group
Measured: 24 weeks
Changes in partial Mayo score over time up to week 24 relative to baseline in each group
Measured: 24 weeks
Changes in quality of life, assessed by short IBD Questionnaire (sIBDQ), and work productivity, assessed by Work Productivity and Activity Impairment Questionnaire (WPAIQ), at week 8 and 24 relative to baseline in each group
Measured: 24 weeks
Changes in inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) over time up to week 24 in each group
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start3 Jun 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327790
- Sponsor's protocol ID
- Pro00117170
- Status last verified
- May 2026
- First submitted
- 25 Mar 2022
- Last updated
- 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual-center, Double Blind, Randomized Placebo-controlled Pilot Trial of Concomitant Lyophilized Fecal Microbiota Transplantation (LFMT) and Biologic Therapy (Vedolizumab or Ustekinumab) for the Induction of Remission in Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT05327790
- Acronym / sponsor ID
- Pro00117170
- Conditions
- Ulcerative Colitis
- Keywords
- FMT, Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Apr 2022 (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.
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Detailed description
This is dual-center, randomized, double-blind, placebo-controlled pilot trial for UC patients with active disease who are being initiated on treatment with vedolizumab or ustekinumab.
The study will recruit 40 outpatients at 2 Canadian healthcare centres at the University of Alberta Hospital (University of Alberta), and the University of Manitoba.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LFMT capsules + vedolizumab | Experimental | Drug: Lyophilized fecal microbiota (LFMT)The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants. |
| Placebo capsules + vedolizumab | Placebo comparator | Other: PlaceboThe placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules. |
| LFMT capsules + ustekinumab | Experimental | Drug: Lyophilized fecal microbiota (LFMT)The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants. |
| Placebo capsules + ustekinumab | Placebo comparator | Other: PlaceboThe placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older but less than 75 years of age
- Able to provide informed consent
- Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
- Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score >1 with disease that extends 15 cm or more from the anal verge
- Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
Key exclusion criteria (23 listed)
- Severe UC requiring hospitalization
- Indeterminate colitis
- Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Abdominal surgery within the past 60 days
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 (LFMT)vedolizumab or ustekinumab + FMT vs placebo | Drug | LFMT capsules + ustekinumab, LFMT capsules + vedolizumab |
| PlaceboPlacebo | Other | Placebo capsules + ustekinumab, Placebo capsules + vedolizumab |
Primary outcome
Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).
Time frame: 24 weeks
SAE of interest is defined as one of the following: * An infection attributable to FMT * Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy * Hospitalization due to UC or an infection attributable to FMT * Mortality due to UC or an infection attributable to FMT SAE of interest is defined as one of the following: * An infection attributable to FMT * Worsening UC, defined as requiring rescue therapy such as increase in steroid dose or change in biologic or colectomy * Hospitalization due to UC or an infection attributable to FMT * Mortality due to UC or an infection attributable to FMT
9 secondary outcomes
Proportion of participants in each group with adverse events during the study up to week 24, including nausea, vomiting, abdominal pain, worsening diarrhea, constipation or fevers
Time frame: 24 weeks
Proportion of participants who achieve clinical remission, defined as total Mayo score ≤ 2 with no individual subscore > 1, at week 8 and 24 in each group.
Time frame: 24 weeks
Proportion of participants who achieve clinical response
Time frame: 24 weeks
Proportion of participants who achieve symptom remission, defined as partial Mayo score < 2 with no individual subscore > 1, at week 8 and 24 in each group
Time frame: 24 weeks
Proportion of participants who achieve symptom response, defined as reduction in partial Mayo score ≥ 2 points from baseline and ≥ 30% from baseline and decrease in rectal bleeding score of ≥ 1point from baseline, at week 8 and 24 in each group
Time frame: 24 weeks
Proportion of participants who achieve endoscopic improvement, defined as Mayo endoscopic subscore ≤1, at week 8 and 24 in each group
Time frame: 24 weeks
Changes in partial Mayo score over time up to week 24 relative to baseline in each group
Time frame: 24 weeks
Changes in quality of life, assessed by short IBD Questionnaire (sIBDQ), and work productivity, assessed by Work Productivity and Activity Impairment Questionnaire (WPAIQ), at week 8 and 24 relative to baseline in each group
Time frame: 24 weeks
Changes in inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) over time up to week 24 in each group
Time frame: 24 weeks
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 6 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized fecal microbiota (LFMT) in people with Ulcerative Colitis, run by University of Alberta at 1 site 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 9 inclusion and 23 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT). (time frame: 24 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 6 May 2026.