Ulcerative colitis affects approximately 80,000 Canadians and is thought to arise from a disordered immune response to gut contents in predisposed individuals. Current therapies for UC remain expensive and imperfect with 50% of patients needing hospitalization and 20% requiring colectomy at some time during the course of their illness. Fecal Microbial Transplantation (FMT) is the administration of stool from a healthy screened to a patient and has shown effective in the treatment of C. diff. IMAGINE investigators were the first in the world to conduct an RCT of FMT to induce remission in active ulcerative colitis (UC). The seminal study showed positive results and spurred growing interest from researchers, funders and patients. As such, the IMAGINE Network initiated the CRAFT study (Ulcerative Colitis Remission through Antibiotics & Fecal Transplantation) to investigate whether the effectiveness of FMT to induce remission in UC patients can be enhanced with an antibiotic pre-treatment.
A total of 76 subjects were recruited and randomized to receive treatment or placebo. The study had an initial target of 80 subjects however, due to challenges related to COVID it became difficult to collect and administer FMT preparations and so it was decided to close out the study. Analysis is currently underway and final results will be shared via publication in scientific meeting and journal. However, interest in this study from the patient and research community has already been tremendous. Patients with UC from across North America were keen to participate and many even travelled as far as 4 hours to join the study. Dr. Tariq Iqbal (University Hospitals Birmingham, UK) is collaborating with Dr. Moayyedi to launch a complementary study in Europe evaluating the best route to administer FMT in UC patients. Dr. Paul Moayyedi and Dr. Michael Surette participated in scientific podcasts by FutureTech to discuss the potential of FMT and microbiome. Furthermore, a lay podcast by Guts & Glory featuring Dr. Paul Moayyedi and Ziyaad Mia (a study participant) was also held reaching over hundreds of stakeholders.
Also noteworthy is that this research study is being complemented by several other studies. The Network is also supporting additional trials that are investigating the efficacy of FMT to treat Crohn’s disease, Pouchitis and Major Depression in patients with IBS. Also, a qualitative research study, led by IBD Nurse Practitioner and co-funded by Crohn’s and Colitis Canada, is looking into patient perceptions of FMT, specifically comparing experiences before and after treatment, and showing how expectations before the treatment administration measure up to real-life experiences. The results from this study will be indispensable in addressing major concerns that may be preventing more patients from seeking out FMT treatment, as well as providing recommendations for improving patient experiences throughout such treatments. Finally, another IMAGINE-supported study, led by Dr. Deborah Marshall, is conducting a Discrete-Choice Experiment (DCE) to quantify patient preference of FMT compared to other conventional treatment options. These complementary studies will better inform health policy-makers in making decisions regarding FMT coverage.