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Fecal microbial transplant (Western University) is an investigational live biotherapeutic product for the treatment of unexplained atherosclerosis. It is being studied in a Phase 1 clinical trial (NCT04410003) at Western University, Canada, led by Principal Investigator J. David Spence. The therapy involves the administration of fecal microbiota harvested from healthy donors who exhibit a 'Protected phenotype'—individuals with high levels of traditional risk factors for atherosclerosis but who have not developed the disease. The goal is to repopulate the gut microbiome of patients suffering from severe unexplained atherosclerosis to alter its composition and metabolic output. The primary mechanism is to reduce the production of pro-atherogenic metabolites, such as trimethylamine N-oxide (TMAO) and p-cresylsulfate, with the long-term goal of developing a cultured ecosystem of bacteria as a therapeutic for atherosclerosis.
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