BCaLM research program: A safe & effective lyophilized fecal microbiota transplantation program for chronic gut disorders
Many Canadians live with debilitating chronic gut disorders such as Crohn's or ulcerative colitis (also known as inflammatory bowel disease, or IBD), Clostridium difficile infection (CDI), or both. These disorders lead to increased morbidity and reduce quality of life and productivity for patients and their families. One in every 150 Canadians has IBD, which is the highest rate worldwide. CDI is the number one cause of health care-associated infection (HAI) in Canada, and associated costs are approximately $300 million per year. An added concern is the recent sharp increase in community-associated CDI rates in previously healthy individuals. Recurrence of CDI following treatment with antibiotics is approximately 30%, increasing to 60% after two or more recurrences.
The key reason for IBD and CDI is thought to be a major imbalance between good and harmful bacteria in the gut (also known as dysbiosis). Current treatments for these conditions are ineffective and costly, and do not establish beneficial bacteria (or microbiota) in the gut. Fecal transplantation, also known as fecal microbiota transplantation (FMT), is a promising new treatment that uses stool from a healthy screened donor to restore the healthy microbiota in the colon. However, FMT remains unavailable in most health care facilities in Canada despite high demand. Dr. Lee regularly receives phone calls and e-mails from patients with chronic gut conditions requesting FMT. FMT is not yet licensed for routine clinical use and out of desperation, some patients have explored the option of performing FMT at home using unscreened donor stools. One of the major challenges of establishing and sustaining an FMT program is the lack of suitable donors and the laboratory support to manufacture FMT. In order to improve availability and reduce cost, this program will use Lyophilized (freeze-dried) FMT, L-FMT. Dr. Lee has used L-FMT to 60 patients with CDI and its result is similar to fresh/frozen FMT.
The BCaLM (British Columbia Associated Lyophilized Microbiota Program) aims to: 1) establish the safety of L-FMT through long-term follow-up of recipients; and 2) establish an effective and safe program to deliver L-FMT across Canada. A multi-site study will evaluate the efficacy of L-FMT, and the results will be used to direct further research and establish capacity for L-FMT. The findings can offer a readily available, cost-effective, and improved treatment option for people with chronic gut disorders.