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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04926103




Registration number
NCT04926103
Ethics application status
Date submitted
12/05/2021
Date registered
14/06/2021

Titles & IDs
Public title
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Scientific title
Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
Secondary ID [1] 0 0
FUEL001
Universal Trial Number (UTN)
Trial acronym
FUEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis Flare 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fecal Microbiota transplant (FMT)

Experimental: Open label FMT therapy - FMT from a related or unrelated healthy donor screened for known communicable disease


Other interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of FMT donors at inducing UC remission
Timepoint [1] 0 0
9 weeks
Primary outcome [2] 0 0
Efficacy of FMT at maintaining remission in UC
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Efficacy of FMT at in inducing histological remission in active UC
Timepoint [1] 0 0
9 weeks
Secondary outcome [2] 0 0
Efficacy of FMT at relieving PRO2 symptoms
Timepoint [2] 0 0
9 weeks
Secondary outcome [3] 0 0
Efficacy of FMT at improving Quality of life
Timepoint [3] 0 0
9 weeks and 3 years
Secondary outcome [4] 0 0
Adverse effects of FMT
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Stool microbiota predicting FMT success
Timepoint [5] 0 0
9 weeks
Secondary outcome [6] 0 0
Mucosal microbiota predicting FMT success
Timepoint [6] 0 0
9 weeks

Eligibility
Key inclusion criteria
1. Patients aged 18 or over
2. Active UC defined as a Mayo score (7) >3
3. A Mayo endoscopic score (7) >0
4. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participating in another intervention study for UC
2. Unable to give informed consent
3. Severe comorbid medical illness
4. Severe UC requiring hospitalization.
5. 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.
6. Antibiotic therapy in the last 30 days.
7. Pregnant women.
8. Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.
9. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L
10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2029
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Hamilton Health Sciences Corporation
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Moayyedi, MD
Address 0 0
HHSC/McMaster
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melanie A Wolfe, CCRP
Address 0 0
Country 0 0
Phone 0 0
9055212100
Fax 0 0
Email 0 0
wolfe@hhsc.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Approach investigator to ask for anonymized dataset

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data will be available after study completion - estimated 7 years
Available to whom?
Any researcher evaluating the efficacy of FMT in ulcerative colitis
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04926103