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FMT capsules (Massachusetts General Hospital) is an investigational live biotherapeutic product consisting of oral, frozen capsules containing the complete fecal microbiota derived from healthy, lean donors. Developed by Massachusetts General Hospital in collaboration with Seres Therapeutics, the therapy is designed to modulate the gut microbiome of individuals with obesity and insulin resistance to improve systemic metabolism. The intervention was evaluated in the Phase 1/2 FMT-TRIM trial (NCT02530385), which demonstrated successful engraftment of donor bacteria in the recipients' intestines that persisted for at least 12 weeks. However, the study found no clinically significant improvements in insulin sensitivity, body weight, or other metabolic parameters compared to placebo.
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