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The Feces Category

Interest in fecal transplants as a way to replace gut microflora to treat recurrent Clostridium difficile infections has been piqued in recent years, and a study published in the New England Journal of Medicine about a year ago showed that fecal microbiota transplants were more effective than vancomycin therapy for treating recurrent C. difficile infections

Shortly after that, the US Food and Drug Administration moved to regulate FMT procedures, indicating that it considers it a biologic. The agency later said it was exercising enforcement discretion, thus allowing FMT to be used to treat recurrent C. diff. without doctors having to file an Investigational New Drug application.

Still, a trio of researchers argues in Nature this week that FDA should regulate feces as a tissue, rather than as a biologic, or give it its own category.

"Although treating it as a drug creates strict requirements to protect patients, it limits access to care," say Mark Smith from MIT, Colleen Kelly at Brown University, and MIT's Eric Alm. "Reclassifying stool as a tissue product or giving it its own classification, as the FDA does for blood, would keep patients safe, ensure broad access, and facilitate research."

Smith, a PhD candidate, is a co-founder of OpenBiome, a feces biobank.

Regulating feces as a tissue will also enable further study of fecal transplants for conditions beyond C. diff., the researchers say. FMT has been floated as a possible treatment for inflammatory bowel disease and obesity.

"I think regulating it as a tissue product would both provide access as needed and the research that could bring some pretty exciting new treatments on the scene," Smith tells LiveScience.

The Scan

Hormone-Based Gene Therapy to Sterilize Domestic Cat

A new paper in Nature Communication suggests that gene therapy could be a safer alternative to spaying domestic cats.

Active Lifestyle Linked to Type 2 Diabetes Prevention in People at High Genetic Risk

A study in the British Journal of Sports Medicine shows that an active lifestyle goes a long way in type 2 diabetes prevention.

Beneficial, Harmful Effects of Introgression Between Wild and Domesticated European Grapes

A paper in PNAS shows that European wild grapevines were an important resource for improving the flavor of cultivated wine grapes.

Genetic Ancestry of South America's Indigenous Mapuche Traced

Researchers in Current Biology analyzed genome-wide data from more than five dozen Mapuche individuals to better understand their genetic history.