ERUAND PANCREATIC ENZYME PRODUCT (PEP) IN PATIENTS WITH CYSTIC FIBROSIS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 大约85%的囊性纤维化（CF）患者患有胰腺外分泌功能不全（EPI）。 EPI的症状包括胀气、腹胀、腹泻和稀便、脂肪便或臭便，所有这些都是由于脂肪、蛋白质吸收不良引起的，在较小程度上也是碳水化合物。 这些影响的发生是因为胰腺不能产生正常数量的消化酶（分解食物的蛋白质）。 大多数患有CF和EPI的儿童和成人都使用含有消化酶的胶囊进行治疗。 这种治疗方法已经使用了30多年，许多人认为它是有效的。 然而，这些产品从未接受过美国食品和药物管理局（FDA）的正式审查，而这是目前在美国销售的所有药物所要求的。 几年前，在欧洲和美国销售的一些非常高剂量的胰酶被发现会导致一些患者的肠道问题。 当酶的剂量降低时，这个问题就消失了。 FDA现在要求所有生产胰酶的公司在对照临床研究中测试其产品的有效性和安全性。 这项研究的目的是观察一种名为Eurand PEP的新型胰酶制剂（PEP）是否能改善CF和EPI患者与安慰剂相比对脂肪、蛋白质和可能的碳水化合物的消化。 Eurand PEP是根据强度（酶含量）大小不同的胶囊。 所有受试者将在一个治疗期接受PEP，在另一个治疗期接受安慰剂。 这是一项随机、双盲、交叉研究。

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, carboyhydrates. These effects occur because the pancrease 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 research study is to see if a new pancreatic enzyme preparation (PEP) called Eurand PEP, improves digestion of fats, proteins, and possibly carbohydrates compared with a placebo in patients with CF and EPI. Eurand PEP are capsules that vary in size according to the strength (enzyme content). All participants will receive PEP for one treatment period and placebo for the other treatment period. This is a randomized, double-blind, cross-over study.