Proton Pump Inhibitors (PPI) and Fat Absorption in Subjects With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Coefficient of Fat Absorption
研究概览
简要总结
This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. Markers of fat absorption will be measured after each treatment course.
详细描述
Fat malabsorption contributes to poor nutritional status in people with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). Prescribing gastric acid-reducing agents such as proton pump inhibitors (PPIs) and histamine receptor antagonists (H2RAs) as an adjunct to pancreatic enzyme replacement therapy (PERT) to improve PERT efficacy and dietary fat absorption has become accepted clinical practice in CF, despite limited evidence to support the practice. Establishing the efficacy and true health benefit of acid suppression for nutritional status and outcomes in CF is particularly important in light of potential health risks and cost associated with long-term or even lifetime use of these medications.
This study aims to characterize changes in fat malabsorption using the coefficient of fat absorption (CFA) as the primary endpoint in subjects who are on and off acid suppression with a PPI in addition to PERT. Additionally, the SmartPill® will be used to evaluate duodenal power of hydrogen (pH) while on and off acid suppression, and the malabsorption blood test (MBT) will be used to characterize changes in fat absorption. Associations will be explored between changes in nutritional status (weight, height, BMI), clinical GI symptoms, and quality of life in subjects treated with PPI vs. placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis and pancreatic insufficiency (Fecal elastase <200 ug/g stool)
- •Age ≥12 years
- •In usual state of good health
- •Willing to participate in a four-month study with three visits
排除标准
- •Forced expiratory vital capacity at one second (FEV1) <40% predicted
- •Pregnancy or breast feeding
- •Other illness affecting growth or nutritional status
- •Unwillingness to continue their clinically established PERT dose for the duration of the study
- •Use of other medication that affects dietary fat absorption
- •Allergy to soy products
- •Allergy to safflower products
- •For subjects ≥18 years, celiac disease or allergy to gluten
研究组 & 干预措施
Omeprazole
Subjects will take omeprazole 20mg daily for 28 days, then undergo assessments of fat absorption.
干预措施: Omeprazole 20mg Capsule (Drug)
Placebo
Subjects will take a placebo daily for 28 days, then undergo assessments of fat absorption.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Coefficient of Fat Absorption
时间窗: After 28 days of treatment or placebo
Gold standard measurement of fat malabsorption
次要结局
- Duodenal pH(After 28 days of treatment or placebo)
- Fat Absorption Via Malabsorption Blood Test(After 28 days of treatment or placebo)