Craig Haifer, PhD, CRI Clinical Innovator

Cancer immunotherapy with immune checkpoint inhibitors (ICI) has revolutionized the treatment and outcomes for multiple cancers in the past 10 years. This has led to sustained remission and cure in some patients even when diagnosed with advanced disease. However, side effects such as diarrhea and colitis are somewhat common, affecting up to 40% of patients. This immune mediated colitis seen with ICIs has clinical and endoscopic similarities found in ulcerative colitis (UC) and is typically remedied with therapies used to treat this disease. 

Fecal microbiota transplantation (FMT) introduces fecal microbiota derived from a healthy donor into a patient’s stomach. It has been proven effective in the management of various forms of colitis similar to ICI’s including C.difficile infection and UC. There could be value in using FMT to treat ICI colitis. It is currently used around the world to treat various forms of bowel inflammation and can be given at the time of a colonoscopy or made into capsules that are swallowed. 

We believe a short course of oral FMT in can induce remission of and can lead to a reduction in overall corticosteroid use, hospitalization, and an early resumption of their cancer immunotherapy. The safety and efficacy of this hypothesis will be strictly monitored.  If successful, FMT can be used earlier in the disease process before hospitalization is required, which may enable the continuation or early resumption of lifesaving cancer immunotherapy. 

The study will also provide a greater understanding of how a patient’s gut bacteria can influence the development of immunotherapy side effects and can guide the development of new therapies that target specific parts of the gut microbiome. 

Projects and Grants

Orally administered fecal microbiota transplantation in the management of immune checkpoint inhibitor associated colitis 

St. Vincent’s Hospital Applied Medical Research Institute | Colorectal Cancer | 2023