Our Partnership with OpenBiome

The University of Minnesota Microbiota Therapeutics Program is partnering with OpenBiome, a non-profit organization operating in Boston, to provide safe microbiota transplant to patients suffering with recurrent and refractory Clostridioides difficile infections. Intestinal Microbiota Transplantation (also known as Fecal Microbiota Transplantation) is recognized as a highly effective treatment option for C. difficile infections. However, this treatment is still quite novel and there are many unknowns. There is mounting evidence that certain patient populations suffering with C. difficile infections are more difficult to cure, including patients with inflammatory bowel disease, patients with kidney failure, elderly patients. Many patients also suffer with post-infection irritable bowel syndrome. Large scale, pragmatic clinical trials that track outcomes of treatments are essential for development of optimal treatment regimens. Our program manufactures microbiota transplant products in different formulations. The volunteer stool donor program is overseen by the Institutional Review Board and monitored by the Clinical and Translational Science Institute of the University of Minnesota. All manufacturing is done in accordance with the FDA-approved Investigational New Drug Application using Good Manufacturing Practices protocols. OpenBiome distributes these products to many clinical programs across the United States and ensures collection of treatment outcome data into de-identified registries. All clinical programs are encouraged to participate in the American Gastroenterological Association FMT registry

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