An interventional study of Fecal Microbiota transplant (FMT) in Ulcerative Colitis Flare, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FMT from a related or unrelated healthy donor screened for known communicable disease
Other: 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
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).
Time frame: 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
Time frame: 3 years
Efficacy of FMT at in inducing histological remission in active UC
Histological remission with no active inflammation on rectal and sigmoid biopsies
Time frame: 9 weeks
Efficacy of FMT at relieving PRO2 symptoms
A score of zero on the first two questions of the Mayo Score
Time frame: 9 weeks
Efficacy of FMT at improving Quality of life
Improvement in quality of life from baseline measured by EQ5D
Time frame: 9 weeks and 3 years
Adverse effects of FMT
Adverse effects associated with FMT therapy
Time frame: 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
Time frame: 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
Time frame: 9 weeks
Plan to share: Yes — Approach investigator to ask for anonymized dataset
Supporting information: Study protocol, Sap, Icf, Csr
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