The U.S. Food and Drug Administration has approved a feces-based microbial treatment to be used to prevent a recurring diarrheal infection that can become life-threatening, Ars Technica reports.
According to the news outlet, researchers have strained to harness the protective qualities of the complex, diverse, yet variable microbial colonies found in healthy people’s intestines and stool that could be used for restoring balance and blocking diarrheal infection.
However, researchers said their understanding of what makes a microbiome healthy, functional, and protective remains incomplete.
Doctors, meanwhile, pushed ahead, informally trying an array of methods to transplant fecal microbiota from healthy donors to the guts of patients—via enemas, tubes through the nose, and oral poop-packed capsules.
Switzerland-based Ferring Pharmaceuticals, the maker of Rebyota, a blend of donor stool, saline, and laxative solution given in a single treatment as an enema in 2018 when it purchased its developer, celebrated the approval.
“We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs. This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development,” Ferring President Per Falk said.
He added: “Today’s announcement is not just a milestone for people living with recurrent C. difficile infection, but also represents a significant step which holds promise that many other diseases might be better understood, diagnosed, prevented, and treated using our rapidly evolving insights on the role of the microbiome in human health and disease.”
Read the full report at Ars Technica.
