Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Improvements in essential fatty acid (EFA) and choline status over a 12-month period.
研究概览
简要总结
The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).
详细描述
Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. The purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month period, every day, will correct the problem people with CF and PI have with absorbing fat and choline. Participation will help CF doctors and other healthcare professionals learn more about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status.
The study will enroll a total of 78 participants from Children's Hospital of Philadelphia (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half will receive a placebo (with no active supplement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as having cystic fibrosis (CF) with pancreatic insufficiency (PI)
- •Subjects aged 6 to 17 years of age
- •In usual state of good health
- •Family and subject commitment to the 18-month study protocol
- •Fecal elastase < 15µg/g stool
排除标准
- •Forced expiratory volume at one second, % predicted (FEV1) < 40% predicted
- •Other chronic health conditions that may affect GI absorption, growth, dietary intake, nutritional status
- •Liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant
- •Participation in another CF nutrition-related intervention study
- •Regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements
- •Home parenteral lipid administration (i.e., intralipids)
结局指标
主要结局
Improvements in essential fatty acid (EFA) and choline status over a 12-month period.
时间窗: 12-month period
次要结局
- Improvements in growth, nutritional, and pulmonary status over an 18-month period.(18-month period)
研究者
Walter A. Shaw, Ph.D
Principle Investigator
Avanti Polar Lipids, Inc.