Ulcerative Colitis FlareFUELNCT04926103
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
A study testing Fecal Microbiota transplant (FMT) in people with Ulcerative Colitis Flare, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis Flare
- What is being tested?
- Fecal Microbiota transplant (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2022to 1 May 2029
- Phase
- Interventional
- 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
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) >3
- A Mayo endoscopic score (7) >0
- Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
Who cannot join
- Participating in another intervention study for UC
- Unable to give informed consent
- Severe comorbid medical illness
- Severe UC requiring hospitalization.
- Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
- Antibiotic therapy in the last 30 days.
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- Pregnant women.
- Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.
- Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L
- Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
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
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, L8N 3Z5
Paul Moayyedi, MD, 905-521-2100 ext. 76764, moayyep@mcmaster.ca
Melanie A Wolfe, CCRP, 905-521-2100 ext. 22060, wolfe@hhsc.ca
About this study
Official title: Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
Read the detailed description
This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.
- Conditions
- Ulcerative Colitis Flare
- Being tested
- Fecal Microbiota transplant (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota transplant (FMT)Other
Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Open label FMT therapy | Experimental | FMT from a related or unrelated healthy donor screened for known communicable disease Receives: Other: Fecal Microbiota transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of FMT donors at inducing UC remission
Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).
Measured: 9 weeks
Efficacy of FMT at maintaining remission in UC
Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy
Measured: 3 years
Secondary outcomes (6)
Efficacy of FMT at in inducing histological remission in active UC
Histological remission with no active inflammation on rectal and sigmoid biopsies
Measured: 9 weeks
Efficacy of FMT at relieving PRO2 symptoms
A score of zero on the first two questions of the Mayo Score
Measured: 9 weeks
Efficacy of FMT at improving Quality of life
Improvement in quality of life from baseline measured by EQ5D
Measured: 9 weeks and 3 years
Adverse effects of FMT
Adverse effects associated with FMT therapy
Measured: 3 years
Stool microbiota predicting FMT success
Comparison of stool microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful
Measured: 9 weeks
Mucosal microbiota predicting FMT success
Comparison of mucosal microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jul 2022
- Primary completion1 Oct 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis FlareStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label study with all UC patients receiving FMT.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Paul Moayyedi, Hamilton Health Sciences Corporation
- Investigators
- Paul Moayyedi, MD, Principal investigator, HHSC/McMaster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926103
- Sponsor's protocol ID
- FUEL001
- Acronym
- FUEL
- Status last verified
- Sep 2024
- First submitted
- 12 May 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Approach investigator to ask for anonymized dataset
Publications
Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
PubMed 25857665
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
- ClinicalTrials.gov ID
- NCT04926103
- Acronym / sponsor ID
- FUEL / FUEL001
- Conditions
- Ulcerative Colitis Flare
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 14 Jun 2021 (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 investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
Detailed description
This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label study with all UC patients receiving FMT.
| Arm | Type | Receives |
|---|---|---|
| Open label FMT therapy | Experimental | Other: Fecal Microbiota transplant (FMT)FMT from a related or unrelated healthy donor screened for known communicable disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) >3
- A Mayo endoscopic score (7) >0
- Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
Key exclusion criteria (10 listed)
- Participating in another intervention study for UC
- Unable to give informed consent
- Severe comorbid medical illness
- Severe UC requiring hospitalization.
- Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
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 |
|---|---|---|
| Fecal Microbiota transplant (FMT)Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years | Other | Open label FMT therapy |
Primary outcome
Efficacy of FMT donors at inducing UC remission
Time frame: 9 weeks
Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).
Efficacy of FMT at maintaining remission in UC
Time frame: 3 years
Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy
6 secondary outcomes
Efficacy of FMT at in inducing histological remission in active UC
Time frame: 9 weeks
Efficacy of FMT at relieving PRO2 symptoms
Time frame: 9 weeks
Efficacy of FMT at improving Quality of life
Time frame: 9 weeks and 3 years
Adverse effects of FMT
Time frame: 3 years
Stool microbiota predicting FMT success
Time frame: 9 weeks
Mucosal microbiota predicting FMT success
Time frame: 9 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 1 Oct 2024.
- Background: PubMed 25857665Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
- Individual participant dataSharing planned: Yes. Approach investigator to ask for anonymized dataset
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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.
Paul Moayyedi, MD principal investigator
HHSC/McMaster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota transplant (FMT) in people with Ulcerative Colitis Flare, run by Hamilton Health Sciences Corporation 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 4 inclusion and 10 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 1 Oct 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Melanie A Wolfe, CCRP (9055212100 ext. 22060, wolfe@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of FMT donors at inducing UC remission (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04926103, which also lists 1 linked publication.
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 1 Oct 2024.