amit kulkarni

Minnesota Cancer Clinical Trials Network Funds Restorative Microbiota Therapy Study

The Minnesota Cancer Clinical Trials Network (MNCCTN) is happy to announce the funding of three studies as part of the network’s inaugural grant program. The program, announced in January 2021, was intended to encourage the development of trials for the MNCCTN and broaden the depth and reach of clinical trials offered to cancer patients in Greater Minnesota. The three projects will each receive up to $125,000 for the initial funding cycle. Awardees will work in partnership with the MNCCTN HUB team on development and implementation of their studies over the next year.  

The second award funded in MNCCTN’s grant program was part of the  Community Site Award, Option B category. This category was open to any MNCCTN partner organization, research or clinical. The category’s awardee is Amit Kulkarni, MBBS, from MNCCTN’s research partner, the Masonic Cancer Center, University of Minnesota, for the project “A Phase-2 trial testing the safety and feasibility of Restorative Microbiota Therapy (RMT) in patients with steroid refractory severe immune-checkpoint inhibitor induced colitis.”

Dr. Kulkarni’s study aims to assess the efficacy, safety, and feasibility of oral RMT in patients with refracted immune-mediated diarrhea and colitis (IMDC). IMDC is a common adverse effect of taking immune checkpoint inhibitors and impairs quality of life for patients. Novel treatments are needed to help improve symptoms for patients, and RMT could be an option to increase gut microbial diversity, something that is often lost in patients with colitis. Once preliminary data is collected in this study, Dr. Kulkarni hopes to conduct a larger randomized trial to gain further insight.

MNCCTN is excited to work with Dr. Kulkarni and the Masonic Cancer Center, as well as continuing to grow our research partnership. The study fits seamlessly with MNCCTN’s mission, and the network is glad to support research that seeks to improve the quality of life for cancer patients in Greater Minnesota and the state as a whole.