Ulcerative ColitisPhase 2NCT04202211
FMT for Remission of Active Ulcerative Colitis in Adults
A Phase 2 study testing FMT oral and FMT enema in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by University of British Columbia at 3 sites in Canada.
Trial summary
The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- FMT oral and FMT enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2022to Dec 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Able to provide informed consent.
- Willing and able to comply with all the required trial procedures
- Active ulcerative colitis as defined by Mayo score > 3 AND Mayo endoscopic sub-score > 1 (within 30 days before enrollment, or at baseline)
Who cannot join
- Planned or actively taking another investigational product
- Abdominal surgery within the past 60 days
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L at - Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Peripheral white blood cell count > 35.0 x 109/L at enrollment AND temperature > 38.0oC
- Active infectious diarrhea at the time of enrolment
- Increase in medical therapy for UC within 3 months of enrollment. Continued treatment with stable dose of 5-ASA, azathioprine, 6-mercaptopurine, cyclosporine, prednisone and/or anti- TNF agents for at least 3 months of is allowed
Show all 13Show fewer
- Severe UC requiring hospitalization at the time of enrolment
- Pregnant or lactating
- History of anaphylaxis to any food
- Requiring oral and/or intravenous systemic antibiotic therapy at the time of study enrolment
- Unwilling to discontinue probiotic (yogurt is allowed)
- Severe underlying disease such that the patient is not expected to survive for at least 30 days.
- Any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
About this study
Official title: A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis
The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- FMT oral, FMT enema, Placebo oral, Placebo enema
- Keywords
- ulcerative colitis, Fecal Microbiota transplant, FMT, Inflammatory bowel disease, IBD
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT oralBiological
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
FMT enemaBiological
lyophilized FMT given via enema (1) twice weekly for total of 8 weeks
Placebo oralOther
placebo given orally (10 capsules) twice weekly for total of 8 weeks
Placebo enemaOther
placebo given via enema (1) twice weekly for total of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo oral & enema | Placebo comparator | twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema Receives: Other: Placebo oral; Other: Placebo enema |
| LYO-FMT oral + placebo enema | Active comparator | twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema Receives: Biological: FMT oral; Other: Placebo enema |
| LYO-FMT oral + LYO-FMT enema | Active comparator | twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema Receives: Biological: FMT oral; Biological: FMT enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of UC
achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1
Measured: 9 weeks following receipt of LYO-FMT
Secondary outcomes (2)
Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]
Safety of LYO-FMT in patients with active UC as determined by absence of adverse events
Measured: up to 5 years post-FMT
UC disease progression
Determine progression of UC based on development of any of the following:
- Clinical flare of UC requiring hospitalization up to 3 months post-FMT
- Increase in dosages of current UC specific medications up to 3 months' post FMT
- Time to colectomy for UC flare up to 12 months' post FMT
- Time to death directly attributable to UC up to 5 years post FMT
- Improvement in clinical response defined by decrease in Partial Mayo score by ≥ 3 points from pre to post LYO-FMT.
- Improvement in patient-reported health related QoL using Valuation of Lost Productivity and (VOLP) and RAND VR12 measured at pre and at 5 weeks, 12 and 24 weeks following LYO-FMT and annually for 5 years
- Reduction in biologic inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) from pre to post LYO-FMT
Measured: immediately after FMT (study) treatment period up to 5 years post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study startMar 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Protocol changed substantially enough to warrant a separate submission
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 British ColumbiaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Canada
- Responsible party
- Principal investigator, Theodore Steiner, University of British Columbia
- Investigators
- Ted Steiner, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202211
- Sponsor's protocol ID
- H19-03882
- Status last verified
- May 2023
- First submitted
- 13 Dec 2019
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04202211
- Acronym / sponsor ID
- H19-03882
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- ulcerative colitis, Fecal Microbiota transplant, FMT, Inflammatory bowel disease, IBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol changed substantially enough to warrant a separate submission
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Canada
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Dec 2019 (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.
The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo oral & enema | Placebo comparator | Other: Placebo oral, Other: Placebo enematwice weekly x 8 weeks: 10 placebo oral capsules + placebo enema |
| LYO-FMT oral + placebo enema | Active comparator | Biological: FMT oral, Other: Placebo enematwice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema |
| LYO-FMT oral + LYO-FMT enema | Active comparator | Biological: FMT oral, Biological: FMT enematwice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide informed consent.
- Willing and able to comply with all the required trial procedures
- Active ulcerative colitis as defined by Mayo score > 3 AND Mayo endoscopic sub-score > 1 (within 30 days before enrollment, or at baseline)
Key exclusion criteria (13 listed)
- Planned or actively taking another investigational product
- Abdominal surgery within the past 60 days
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L at - Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Peripheral white blood cell count > 35.0 x 109/L at enrollment AND temperature > 38.0oC
- Active infectious diarrhea at the time of enrolment
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 |
|---|---|---|
| FMT orallyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks | Biological | LYO-FMT oral + LYO-FMT enema, LYO-FMT oral + placebo enema |
| FMT enemalyophilized FMT given via enema (1) twice weekly for total of 8 weeks | Biological | LYO-FMT oral + LYO-FMT enema |
| Placebo oralplacebo given orally (10 capsules) twice weekly for total of 8 weeks | Other | Placebo oral & enema |
| Placebo enemaplacebo given via enema (1) twice weekly for total of 8 weeks | Other | LYO-FMT oral + placebo enema, Placebo oral & enema |
Primary outcome
Remission of UC
Time frame: 9 weeks following receipt of LYO-FMT
achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1
2 secondary outcomes
Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]
Time frame: up to 5 years post-FMT
UC disease progression
Time frame: immediately after FMT (study) treatment period up to 5 years post-FMT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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. This study is not recruiting at the moment.
Ted Steiner, MD principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT oral and FMT enema in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by University of British Columbia at 3 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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of UC (time frame: 9 weeks following receipt of LYO-FMT). 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 10 May 2023.