“Screening donors on an individual basis is not only expensive—it is also not for the squeamish. Carolyn Edelstein is the executive director of OpenBiome, the first stool bank, which operates in the Boston area and provides physicians and researchers with prescreened fecal matter. Before stool banks existed, Edelstein says, physicians had “shelves and shelves of blenders” in which, if they got as far as finding and screening a donor and acquiring a sample, they would need to puree the donation so it could be siphoned through a colonoscopy tube. The blenders had to be thrown away afterward, as they could not be properly sterilized. It was not a sideline most doctors found alluring.
The 2014 FDA guidelines provided no role for—or regulation of—such organizations. “Limiting donations to people the patient or physician knows would eliminate the possibility of using a stool bank,” says Hoffmann. The guidance was updated in 2016, allowing physicians to use a hospital stool bank, but even then the stool sample had to be obtained under the direction of the treating physician.”