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Fecal microbiota transplant (FMT) is a live biotherapeutic product being investigated by Peking University Sixth Hospital for the treatment of chronic insomnia disorder. [5] The therapy involves transferring gut microbiota from healthy donors to patients to restore a healthy gut microbiome. [3] In a Phase 1/2 clinical trial (NCT05917379), the treatment is administered via oral capsules, with a control group receiving starch-filled placebo capsules. [7] The study aims to evaluate the efficacy of this approach on sleep status, with some patient groups also receiving synbiotics (a combination of probiotics and prebiotics). [7] The proposed mechanism involves modulating the gut-brain axis, as the gut microbiome is believed to play a role in regulating sleep. [2, 5]
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