EURAND PANCREATIC ENZYME PRODUCT MICROTABS IN PEDIATRIC CF PATIENTS

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。 大约85%的囊性纤维化患者有胰腺外分泌功能不全(EPI)。EPI的症状包括放气、腹胀、腹泻，以及疏松、脂肪或臭气熏天的大便，所有这些都是由于脂肪、蛋白质和碳水化合物吸收不良造成的。这些影响的发生是因为胰腺不能产生正常数量的消化酶(分解你吃的食物的蛋白质)。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。这种疗法已经使用了30多年，被许多人认为是有效的。然而，这些产品从未经过美国食品和药物管理局(FDA)的正式审查，而现在在美国销售的所有药物都需要进行正式审查。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受控临床研究中测试其产品的有效性和安全性。本研究的目的是评估Eurand PEP微片在7岁以下的儿童外周感染患者中的安全性和耐受性。

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.