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This fecal microbiota transplant (FMT) is an investigational biological therapy developed by the Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS) for the treatment of type 2 diabetes mellitus and obesity. The intervention involves the oral administration of lyophilized fecal material derived from healthy, lean donors, encapsulated in gelatin capsules. The primary objective is to restore a healthy gut microbiota composition in patients with metabolic dysfunction, thereby improving insulin sensitivity and glycemic control. In the EPIGEN-MICROBIOTA (NCT05076656) Phase II trial, the therapy was evaluated for its ability to modify the intestinal bacterial community and impact epigenetic markers associated with adipose tissue dysfunction in patients already receiving metformin.
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