The successful use of fecal matter to treat severe diarrhea was first recorded more than 1,800 years ago in China. Flash forward to 2014, and the publication of controlled clinical trial evidence demonstrating the effectiveness of “fecal microbiota transplant” (FMT) to treat C. diff infection (CDI).¹ Thomas J. McGarrity, M.D., chief, Penn State Hershey Gastroenterology and Hepatology, has drawn on this evidence to treat twelve patients with recurrent or severe CDI. McGarrity explains, “We’ve administered FMT via a colonoscopic approach to patients with either three or more recurrences of CDI, or severe CDI unresponsive to conventional antibiotic treatment. Some of the patients were critically ill and faced the risk of renal failure. Within forty-eight hours of receiving FMT, clinical improvement was seen and a full recovery was eventually made in all twelve patients. None have experienced any further CDI occurrences.”
The FMT protocol used by McGarrity is IRB-approved and based on American Gastroenterological Association guidelines. McGarrity adds, “We rigorously screened donors to ensure that the transplanted fecal matter did not pose a risk of communicating other diseases or parasites. We also excluded individuals with recent antibiotic use, since that would compromise fecal quality and biodiversity. The rapid improvement we saw in the patients was impressive. The most common side effect reported during follow-up was constipation.”
McGarrity says, “Patients and families readily accepted FMT as an option. It is relatively low-cost and the procedure itself poses little risk. The key factor is safety, quality, and biodiversity of the transplanted fecal matter.”
Currently, the Food and Drug Administration (FDA) considers donated fecal matter a biological agent, and therefore subject to the regulations that apply to such agents. Some have argued for categorizing fecal matter for FMT as a bodily tissue, akin to heart or lung, rather than a drug.² Patients and physicians, on the other hand, are not waiting, with the procedure being done with close family members as fecal transplant donors who do not undergo adequate pre-screening and testing. FMT is also being used to treat a wide array of conditions, including chronic diarrhea, IBD, and Crohn’s disease.
McGarrity comments, “At this point, there is not enough science to warrant the use of FMT across all of these conditions.” For this promising treatment, additional well-controlled clinical trial evidence, proper FDA regulation, rigorous donor screening, and clear patient selection guidelines are needed to establish the legitimate place of FMT in the treatment of CDI.
Thomas J. McGarrity, M.D.
Professor of Medicine
Chief, Penn State Hershey Gastroenterology and Hepatology
Penn State Milton S. Hershey Medical Center
FELLOWSHIP: Gastroenterology, Penn State Milton S. Hershey Medical Center
RESIDENCY: Medicine, Penn State Milton S. Hershey Medical Center
MEDICAL SCHOOL: University of Virginia, School of Medicine
1. van Nood E, Vrieze A, Nieuwdorp M, et al. 2013. Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. N Engl J Med. 368: 130116140046009.
2. Smith MB, Kelly C, Alm EJ. 2014. How to regulate faecal transplants. Nature. 506; 290-291.