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Fecal microbiota transplant (FMT) is a live biotherapeutic product being investigated by the Maimónides Biomedical Research Institute of Córdoba for the selective intestinal decolonization of patients colonized by carbapenemase-producing Klebsiella pneumoniae (Kp-KPC). It is being studied in a Phase 2, randomized, double-blind, placebo-controlled trial called KAPEDIS (NCT04760665). The therapy involves administering encapsulated, lyophilized fecal microbiota from healthy donors to restore a healthy gut microbiome. The intended mechanism is to leverage competitive exclusion and other ecological interactions to eradicate Kp-KPC, thereby reducing the patient's risk of developing subsequent infections, which are often associated with high mortality rates.
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