OpenBiome Applauds New AGA Guidelines on Fecal Microbiota Transplants


OpenBiome applauds the new AGA recommendation on fecal microbiota transplants (FMT) for the majority of patients with recurrent Clostridioides difficile (C. diff) infection. The updated clinical guidelines will help clinicians and patients make informed, evidence-based treatment decisions for recurrent C.diff. In the United States alone, an estimated 500,000 cases of C. diff are reported annually and as many as 30,000 cases result in death. When standard-of-care antibiotic therapies fail, the impact on patients living with recurrent C. diff can be devastating. As a nonprofit microbiome health organization, OpenBiome wants to ensure that all those suffering from this devastating disease have safe access to the appropriate therapeutics. We also join the AGA in drawing attention to a larger need – that more research is needed on optimizing the use of FMT in C. diff and for clinical trials to evaluate the use of FMT in other indications, such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Today’s guidelines do much to further that mission. In partnership with the University of Minnesota which manufactures the investigational FMT and our 735+ clinical partners, OpenBiome will continue to provide safe access to investigational FMT therapies for patients who have exhausted existing options while working closely with the US Food & Drug Administration (FDA) to align with the finalized regulatory guidance on FMT access for C. difficile infection.
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