Fecal Microbiota Transplant is a Promising Treatment

AGA Urges FDA to Streamline Process to Get Treatment to Patients

Jun 12, 2013, 14:58 ET from American Gastroenterological Association

BETHESDA, Md., June 12, 2013 /PRNewswire-USNewswire/ -- Generally, drug development in the U.S. is powered by pharmaceutical company laboratories. In an unusual turn of events, a promising new treatment for debilitating recurrent Clostridium difficile infection has developed outside the usual drug-development process, and the treatment isn't a chemical compound, but microbes that live in the human gut.

Every year more than 14,000 Americans die from C. difficile, a serious infection that causes diarrhea[1]. Prolonged use of antibiotics raises the risk of C. difficile, which is increasingly common in hospitals. C. difficile infections can be hard to eliminate. Physicians need better options for their patients.  

Physicians have discovered that giving C. difficile patients microbes from the human gut can cure the infection. The key is transplant of fecal material, which contains a highly complex and dense community of microbes that include bacteria, fungi and viruses, many of which have not been fully characterized.

This microbiome is a dynamic and living consortium that can change over time in ways that scientists cannot currently fully predict. The AGA Center on Microbiome Research and Education has a panel of scientists and physicians who are expert on the complexities of the microbiome and its potential to improve patient care.

Some physicians administer fecal microbiota transplants (FMT) to help treat recurrent C. difficile. Because FMT is not approved by the U.S. Food and Drug Administration (FDA) for any therapeutic purposes, an investigational new drug (IND) application is needed to use FMT to treat any disease, including recurrent C. difficile infection.

AGA appreciates the importance of FDA's oversight to ensure the right patients are being treated with FMT, that it is done safely, and that patients consent to treatment and are followed for adverse events. However, we recognize the urgent need for patients to receive effective treatment of their infection. 

AGA and other organizations are working with the FDA to design a carefully vetted approach that streamlines the IND process and allows clinicians to more easily obtain approval to deliver FMT in the appropriate clinical setting.

Through the AGA Center on Microbiome Research and Education, the AGA offers expert spokespersons who can discuss FMT:

Gary D. Wu, MD, Chair of the AGA Center on Microbiome Research and Education; Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia
Dr. Wu is a physician-scientist at the University of Pennsylvania who studies host-gut microbial interactions and their impact on various disease states in both animal models and humans. He is one of the leaders of the Penn Human Microbiome Project funded by NIH that, together with investigators at the Children's Hospital of Philadelphia, is currently investigating the impact of diet on the gut microbiome as a therapeutic target for the treatment of Crohn's disease. 

Gail Hecht, MD, MS, AGAF Professor of Medicine; Microbiology/Immunology and Chief, Gastroenterology and Nutrition at Loyola University Medical Center, Maywood, IL
Dr. Hecht is a gastroenterologist with a Masters degree in Microbiology. She has investigated host-microbial interactions in the GI tract for over 20 years and follows this field closely. Her training in basic science of the GI tract and microbiology combined with her clinical skills in gastroenterology allow her to communicate the published literature in this area to practicing gastroenterologists in a clinically meaningful way.

Colleen R. Kelly, MD, Clinical Assistant Professor of Medicine, Warren Alpert Medical School of Brown University, Providence, RI
The focus of Dr. Kelly's research and clinical practice is FMT for treatment of C. difficile infection and she has assisted many physicians and institutions in developing FMT protocols. Dr. Kelly has authored a number of papers and abstracts on the subject and was a member of a working group that drafted a best-practices article for treating C. difficile infection with FMT which was published in 2011. She is a principal investigator for the first U.S. clinical trial of FMT to treat relapsing C. difficile infection which is funded by the National Institutes of Health (NIDDK) and is the sponsor of an IND from the FDA (CBER) for this clinical trial. She is on the board of advisors of The Fecal Transplant Foundation.

Lee M. Kaplan, MD, PhD, AGAF, Director, Obesity, Metabolism & Nutrition Institute, Gastrointestinal Unit at Massachusetts General Hospital, Boston
Dr. Kaplan studies the role of the intestinal microbiota and microbiota-diet interactions in the regulation of energy balance and metabolic function. His group has recently demonstrated that alterations in the microbiota after Roux-en-Y gastric bypass mediate weight loss after this operation, suggesting a potential role for FMT in the treatment of obesity and related metabolic disorders.

About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.

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[1] CDC website. Accessed May 29, 2013. http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html

SOURCE American Gastroenterological Association