ABSTRACT
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.
ABSTRACT
BACKGROUND: The safety of 2-h preoperative clear liquid fasts has not been established for overweight/obese pediatric day surgical patients. Healthy children and obese adults who fasted 2 h have small residual gastric fluid volumes (GFVs), which are thought to reflect low pulmonary aspiration risk. We sought to measure the prevalence of overweight/obesity in our day surgery population. We hypothesized that neither body mass index (BMI) percentile nor fasting duration would significantly affect GFV or gastric fluid pH. In children who were allowed clear liquids up until 2 h before surgery, we hypothesized that overweight/obese subjects would not have increased GFV over lean/normal subjects and that emesis/pulmonary aspiration events would be rare. METHODS: Demographics, medical history, height, and weight were recorded for 1000 consecutive day surgery patients aged 2-12 yr. In addition, 1000 day surgery patients (age 2-12 yr) undergoing general endotracheal anesthesia were enrolled. After tracheal intubation, a 14-18F orogastric tube was inserted and gastric contents evacuated. Medications, fasting interval, GFV, pH, and emetic episodes were documented. Age- and gender-specific Center for Disease Control and Prevention growth charts (2000) were used to determine ideal body weight (IBW = 50th percentile) and to classify patients as lean/normal (BMI 25th-75th percentile), overweight (BMI > or = 85th to <95th percentile), or obese (BMI > or = 95th percentile). RESULTS: Of all day surgery patients, 14.0% were overweight and 13.3% were obese. Obese children had lower GFV per total body weight (P < 0.001). When corrected for IBW, however, volumes GFV(IBW) were identical across all BMI categories (mean 0.96 mL/kg, sd 0.71; median 0.86 mL/kg, IQR 0.96). Preoperative acetaminophen and midazolam contributed to increased GFV(IBW) (P = 0.025 and P = 0.001). Lower GFV(IBW) was associated with ASA physical status III (P = 0.024), male gender (P = 0.012), gastroesophageal reflux disease (P = 0.049), and proton pump inhibitor administration (P = 0.018). GFV(IBW) did not correlate with fasting duration or age. Decreased gastric fluid acidity was associated with younger age (P = 0.005), increased BMI percentile (P = 0.036), and African American race (P = 0.033). Emesis on induction occurred in eight patients (50% of whom were obese, P = 0.052, and 75% of whom had obstructive sleep apnea, P = 0.061). Emesis was associated with increased ASA physical status (P = 0.006) but not with fasting duration. There were no pulmonary aspiration events. CONCLUSIONS: Twenty-seven percent of pediatric day surgery patients are overweight/obese. These children may be allowed clear liquids 2 h before surgery as GFV(IBW) averages 1 mL/kg regardless of BMI and fasting interval. Rare emetic episodes were not associated with shortened fasting intervals in this population.
