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Fecal microbiota transplantation (FMT) from the Fred Hutchinson Cancer Center is an investigational biologic therapy being developed for the prevention of acute graft-versus-host disease (aGVHD) in adults undergoing allogeneic hematopoietic cell transplantation (HCT). [1] The product consists of oral encapsulated third-party fecal microbiota from healthy donors. The goal is to restore healthy gut microbiota diversity and commensal bacterial species, which are often disrupted during HCT, to prevent severe aGVHD. [1] A phase II, randomized, double-blind, placebo-controlled trial (NCT06026371) initiated in November 2023 is evaluating an optimized higher-dose formulation with donors selected based on engraftment success from earlier studies. [2, 9] The randomized phase began enrollment in June 2024. [2]
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