Current state of the art of medical foods.

Inflammatory bowel disease (IBD) is one of the five most prevalent gastrointestinal disease burdens in the US, with an overall health care cost of more than USD 1.7 billion. It commonly requires a lifetime of care, and accounts for more than 700,000 physician visits, 100,000 hospitalizations, and disability in 119,000 patients each year. IBD is a multifactorial disease and comprises genetic susceptibility, uncontrolled immune responses, and environmental factors which play a role in the pathogenesis and course of the disease. IBD patients are lifelong on medication, either for induction or maintenance therapy. Current treatment option (corticosteroids, immune suppressants, biologics), administered in mono- or combination therapy, are still unsatisfactory. Due to the nature of disease, 20-40% of patients relapse within the first 12 months. Although modern treatment algorithms have diminished the risk of surgery, the treatments harbor significant side effects, which impacts patients' quality of life. The role of nutrition in IBD has gathered high interest, especially in pediatric Crohn's disease, where studies have shown that exclusive enteral nutrition can induce remission in mild-to-moderate disease comparable to corticosteroids. Thus, gastroenterologists and patients become increasingly aware that specific nutritional interventions offered in addition to the standard of care are an appealing option for a safe long-term disease management. Such specific nutritional solutions should be based on scientific/clinical evidence and specifically designed to address the patients' distinct nutritional requirements. As per definition, these nutrition products fall under the regulatory framework of a Medical Food (Foods for Special Medical Purposes in Europe).