Fecal Microbiota Transplant is a Promising Treatment

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 diarrhea1. 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.

1CDC website. Accessed May 29, 2013.

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