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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是研究囊性纤维化引起的胰腺外分泌功能不全。PEI是一种胰腺产生厚厚的粘液的情况，不允许足够的消化酶到达肠道并帮助分解食物。 尽管FDA已经批准了使用胰酶治疗成人PEI的适应症，但现在要求所有用于治疗儿童PEI的酶都必须安全有效。 这项研究正在观察一种名为胰腺脂肪酶延迟释放胶囊的药物的安全性和有效性，该药物用于治疗与囊性纤维化相关的胰腺外分泌不足。

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.