A DOUBLE-BLIND, RANDOMIZED, MULTI-CENTER, PLACEBO-CONTROLLED,

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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. This research is studying pancreatic exocrine insufficiency [PEI] due to cystic fibrosis. PEI is a condition where the pancreas produces a thick mucous that does not allow enough digestive enzymes to reach the intestines and help break down food. Although the FDA has approved indications for the use of pancreatic enzymes to treat PEI in adults, it now requires that all enzymes used to treat PEI in children be established for safety and efficacy. The study is looking at the safety and effectiveness of a drug called Pancrealipase Delayed Release Capsules, for treatment of pancreatic exocrine insufficiency associated with cystic fibrosis.