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Fecal microbiota transplant (FMT) is an investigational live biotherapeutic product being developed by the Masonic Cancer Center and the University of Minnesota. It is being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial (NCT03692520) for the prevention of infections (bacterial, viral, and fungal) and graft-versus-host disease (GVHD). The trial enrolls patients with acute myeloid leukemia (AML) undergoing intensive chemotherapy and recipients of allogeneic hematopoietic cell transplantation (allo-HCT). [4] The therapy, administered as oral capsules, aims to restore a healthy gut microbiome that has been disrupted by antibiotics and chemotherapy, thereby potentially reducing infection rates and modulating the immune system to prevent GVHD. [3, 7] While the trial did not meet its primary endpoint of reducing overall infection rates, analysis suggests that donor microbiota engraftment may be associated with a lower rate of acute GVHD. [3, 4]
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