Gastroenterology & Hepatology
April 2014, Volume 10, Issue 4
Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a person with dysbiosis, with the intent of repopulating the gut with normal commensal flora. Practiced for centuries as folk medicine, it has fairly recently entered the medical mainstream, showing particular promise in the treatment of refractory or relapsing Clostridium difficile (RCDI) infection. Studies of the safety and efficacy of FMT have moved from anecdotal case reports to randomized controlled trials as the medical community and government attempt to play catch-up on clearly defining the safety, efficacy, and appropriate indications for FMT. Meanwhile, the lay public and alternative health advocates, who may be throwing caution to the wind, have jumped on the FMT advocacy and do-it-yourself bandwagon—a situation that may place a significant burden on health resources down the road if home remedies result in complications.
Concern for public safety led the US Food and Drug Administration (FDA), back in May 2013, to demand the submission of an investigational new drug (IND) application to perform FMT for treatment of RCDI, but this edict was quickly revoked when it was shown to stymie research and access to care for a procedure that appeared to be associated with remarkable efficacy rates. Within a month, the FDA conceded that, although an IND was preferred, it was not required to perform FMT for RCDI and that clinicians should be diligent in acquiring informed consent and screening procedures. New draft guidelines on the subject are available at http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm387023.htm.
A candid editorial on the state of the art, regulatory issues, and future perspectives is planned for an upcoming issue of Gastroenterology & Hepatology. In the current issue, we are very pleased to present a comprehensive review of the efficacy of FMT in gastrointestinal disease by key leaders in the field Dr Lawrence J. Brandt, of the Montefiore Medical Center and Albert Einstein College of Medicine of Yeshiva University in the Bronx, New York, and Dr Olga C. Aroniadis, of the Montefiore Medical Center in the Bronx, New York.
Another feature presented in this issue focuses on the challenges of diagnosis and treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) and the influence of alcohol on liver disease. The article is authored by Dr Mary E. Rinella, of the Northwestern University Feinberg School of Medicine in Chicago, Illinois, and a top-notch multicenter team of thought leaders in the field of hepatology. We also present a useful study, headed by senior author Dr John Evans, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, on identifying patients at risk for common bile duct stones following abnormal intraoperative cholangiography.
Complementing our feature on NAFLD and NASH, we present an interview with Dr Ayako Suzuki, of the University of Arkansas Medical School in Little Rock, on NASH in special populations for our Advances in Hepatology column. Dr Raymond K. Cross Jr, of the University of Maryland School of Medicine in Baltimore, discusses promising developments in telemedicine in patients with inflammatory bowel disease in the Advances in IBD column; Dr Yasser M. Bhat, of the California Pacific Medical Center in San Francisco, provides guidance on the use of tissue adhesives in the Advances in Endoscopy column; and Dr Jeffrey H. Peters, of the University of Rochester Medical Center in New York, discusses surgical treatment of gastroesophageal reflux disease in the Advances in GERD column. In addition, we present an interview with Ms Liesl Hagan, of the Rollins School of Public Health at Emory University in Atlanta, Georgia, on the topic of cost-effectiveness of therapy in our Advances in HCV column.
May this issue of Gastroenterology & Hepatology, packed with clinical insights, better your practice.
Sincerely,
Gary R. Lichtenstein, MD, AGAF, FACP, FACG