The Emerging Therapeutic Role of Medical Foods for Gastrointestinal Disorders.

In addition to drugs approved by the US Food and Drug Administration (FDA) that treat, cure, or mitigate disease, medical foods are a tool to help manage chronic conditions and diseases. A medical food, according to the FDA, is a food that is developed to be eaten or administered enterally under the guidance of a physician and that is meant for the specific dietary management of a condition or disease for which distinctive nutritional requirements, based upon known scientific principles, are established by medical evaluation. A variety of medical foods exist to help manage a wide range of medical conditions, from Alzheimer disease to HIV-associated enteropathy. EnteraGam contains serum-derived bovine immunoglobulin/protein isolate, which has been studied extensively in diarrhea-predominant irritable bowel syndrome, inflammatory bowel disease (IBD), and HIV-associated enteropathy. VSL#3 is a probiotic that is used in pouchitis for patients with ulcerative colitis as well as irritable bowel syndrome. Modulen IBD is a whole-protein, sole-nutrition formulation used to manage the active phase of Crohn's disease. Vivonex is an elemental diet that is used in a variety of diseases associated with severe gastrointestinal dysfunction. Medical foods are safe and must have proven efficacy in helping to manage a variety of gastrointestinal conditions and diseases. These therapies represent tools that can be used prior or in addition to traditional medical therapies. This article discusses the history and development of medical foods under the FDA and concentrates specifically on medical foods used to help manage diseases of the gastrointestinal tract.