SAFETY & EFFICACY OF EURAND PEP IN PATIENTS W/ CYSTIC FIBROSIS AND EPI

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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. A vast majority of patients with Cystic Fibrosis (CF), a respiratory disease, also have a condition known as Exocrine pancreatic insufficiency (EPI). The main symptoms of EPI are gas, bloating, diarrhea, and loose stools, all of which are caused by poor absorption of fats, proteins, and carbohydrates. Most patients that have EPI are treated with pills containing digestive enzymes produced from pig pancreas or other sources. These enzymes have been used for over 30 years, and are thought to be effective. However, these drugs have never been fully tested, which is now required for all drugs distributed in the United States. Due to an incident a few years ago where some very high doses of pancreatic enzymes sold in Europe and the United States were found to cause intestinal problems, the U.S. Food and Drug Administration (FDA) is now requiring all enzyme producers to test the safety and efficacy of their drugs in controlled clinical studies. This research study will determine whether Eurand PEP (a pancreatic enzyme) improves fat, protein, and carbohydrate digestion. The test will be conducted using a double-blind, randomized trial, where neither the doctor, nor the patient know if the patient is using the test drug, or a placebo. The study will find out the safety and efficacy of Eurand PEP compared to that of a placebo.'