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Fecal microbiota transplantation: An underutilized therapy
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Just over one year ago, researchers reported on the low-technological process of fecal microbiota transplantation as a potential therapy for patients with recurrent Clostridium difficile infections.
The procedure — also known as a stool transplant — consists of the transplantation of fecal bacteria from a healthy individual into a patient with the C. difficile infection. The infection may cause diarrhea and/or pseudomembranous colitis.
Despite promising case reports and case series reports regarding fecal microbiota transplantation (FMT), it has not been widely accepted for treating this patient population, according to data presented at the American College of Gastroenterology Annual Scientific Meeting in October 2013.
In May 2013, the FDA proposed that clinicians who wish to perform FMT must obtain an Investigational New Drug application prior to carrying out the procedure. Although this proposal was not formally adopted by federal regulators, many clinicians have stepped back from the approach.
In a paper recently published in Nature, researchers wrote that the FDA should evaluate stool infusions as a tissue product, but not under the same blanket as the drug approval process.
According to Kelly and colleagues, more than a half a dozen clinical trials have been registered to study FMT in inflammatory bowel diseases. Until more data are collected, manipulating the gut microbiome to treat diseases other than C. difficile infections, such as inflammatory bowel disease or obesity, remain speculative.
References:
Rubin DT. The Emerging Role of the Microbiome in the Pathogenesis and Management of Inflammatory Bowel Disease. Presented at the 2013 American College of Gastroenterology Annual Meeting. Oct. 11-16, 2013; San Diego.
Smith MB. Nature. 2014; doi:10.1038/506290a.