EUR-1008-M

EUR-1008-M

• 批准号: 7603246
• 负责人: John Paul Clancy
• 金额: $ 1.49万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603246
• 关键词: Adult; Age-Years; Body Weight; Calories; Carbohydrates; Computer Retrieval of Information on Scientific Projects Database; Daily; Diagnosis; Diet; Dose; Double-Blind Method; Drug Formulations; Eating; Enzymes; Evaluable Disease; Exocrine pancreatic insufficiency; Family suidae; Fatty acid glycerol esters; Female; Food; Funding; Grant; Home environment; Institution; Label; Lipase; Liquid substance; Monitor; Multicenter Trials; Nutritionist; Pancrelipase; Patients; Placebo Control; Preparation; Proteins; Randomized; Research; Research Design; Research Personnel; Resources; Sampling Studies; Screening procedure; Source; Supervision; Time; Titrations; United States National Institutes of Health; aged; cystic fibrosis patients; day; diaries; dosage; experience; male; treatment duration

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 study will be a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in patients with cystic fibrosis and exocrine pancreatic insufficiency. The study sample will consist of a minimum of 30 evaluable male of female patients who are > or equal to 7 years of age, with a body weight of <70kg, a BMI >20kg/m2 for adults or a BMI above the 25th percentile for patients aged 7 through 20 years, and a confirmed diagnosis of CF and EPI. The study design involves a screening period (1-4 days), a dose titration/stabilization period (6 -9 days), a randomized treatment period (approximately 6 days), an open label normalization , a crossover treatment period , followed by a second open-label normalization. The order of treatments will be determined by randomization at the beginning of treatment period 1 only and will carry through the crossover treatment period. The starting dose for treatment will be 1,000 lipase units/kg/meal, with a total dose less than or equal to 2,500 lipase units/kg/meal and less than or equal to 4,000 lipase units/kg/meal, not to exceed 10,000 lipase units/kg/day. All patients will receive a combination of the 4 dosage formulations, which are to be taken with meals. It is recommended that the total dose of pancrelipase (porcine enzyme preparation) being ingested for a meal or snack be dispersed equally (with fluids) before, during, and after the meal of snack. During the study, all patients will consume a diet that will derive 45% if calories from fat, 20% of calories form protein, and 35% of calories from carbohydrate. The sponsor will provide menus from the recommended diet and a nutritionist will discuss all aspects of meal preparation with the patient or guardian. During home treatment periods, patients will record daily food intake and a diary for review by the investigator. During the in-patient portions of the randomized treatment periods, all food will be prepared under the supervision of a nutritionist experienced in the treatment of CF patients. The type and amount of food consumed will be closely monitored during this time.

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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究是一项在囊性纤维化和胰腺外分泌功能不全患者中进行的随机、双盲、安慰剂对照、2种治疗、交叉、多中心试验。研究样本将由至少30名可评估的男性或女性患者组成，这些患者年龄>或等于7岁，体重<70 kg，成人BMI > 20 kg/m2，或7至20岁患者BMI高于第25百分位数，并确诊CF和EPI。研究设计包括筛选期（1-4天）、剂量滴定/稳定期（6 - 9天）、随机化治疗期（约6天）、开放标签标准化、交叉治疗期，随后是第二次开放标签标准化。治疗顺序将仅在治疗阶段1开始时通过随机化确定，并将持续至交叉治疗阶段。治疗起始剂量为1，000脂肪酶单位/kg/餐，总剂量≤ 2，500脂肪酶单位/kg/餐且≤ 4，000脂肪酶单位/kg/餐，不超过10，000脂肪酶单位/kg/天。所有患者将接受4种剂型的组合，随餐服用。建议在餐前、餐中和餐后均匀分散（含液体）用于餐或零食摄入的胰脂肪酶（猪酶制剂）总剂量。 在研究期间，所有患者的饮食中45%的热量来自脂肪，20%的热量来自蛋白质，35%的热量来自碳水化合物。申办者将提供推荐饮食的菜单，营养师将与患者讨论膳食准备的各个方面， 监护人在家庭治疗期间，患者将记录每日食物摄入量和日记，供研究者审查。在随机化治疗期的住院部分，所有食物将在CF患者治疗经验丰富的营养师的监督下制备。在此期间，将密切监测所消耗食物的类型和数量。