EURAND PANCREATIC ENZYME PRODUCT MICROTABS IN PEDIATRIC CF PATIENTS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Approximately 85% of people with cystic fibrosis (CF) have exocrine pancreatic insufficiency (EPI). Symptoms of EPI include gas, bloating, diarrhea, and loose, fatty, or smelly stools, all of which are caused by poor absorption of fats, proteins, and to a lesser extent, carbohydrates. These effects occur because the pancreas is not able to produce normal amounts of digestive enzymes (proteins that break down food that you eat). Most children and adults with CF and EPI are treated with capsules containing digestive enzymes. This treatment has been used for more than 30 years and is thought by many people to be effective. However, these products never underwent a formal review by the US Food and Drug Administration (FDA) as is now required for all drugs sold in the United States. A few years ago, very high doses of some pancreatic enzymes sold in Europe and the United States were found to cause intestinal problems in some patients. This problem disappeared when the doses of the enzymes were lowered. The FDA is now asking all companies that produce pancreatic enzymes to test the effectiveness and safety of their products in controlled clinical studies. The purpose of this study is to evaluate the safety and tolerability of Eurand PEP Microtabs in CF patients with EPI who are younger than 7 years of age.