Use of Pancreatic Enzymes in Short Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Coefficient of Fat Absorption
研究概览
简要总结
Patients with short bowel syndrome have a high mortality rate that is mainly attributed to complications from central lines and long-term intravenous (IV) nutrition. There are few medical therapies to date that improve gut absorption in patients with short bowel syndrome. The primary objective of this study is to evaluate if absorption from the GI tract improves in subjects with short bowel syndrome following therapy with pancreatic enzymes.
详细描述
This is an interventional study of subjects with short bowel syndrome to determine if enteral absorption improves following therapy with pancreatic enzymes. The study will assess enteral absorption and nutritional status at baseline through a series of stool tests, blood tests, and anthropometric measurements. Following approximately ten days of therapy with pancreatic enzymes, the study will reassess enteral absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of a small bowel resection with subsequent dependence on parenteral nutrition for at least three months
- •age 4 years to 65 years
- •usual state of health for the past two weeks with no medication changes
- •able to participate in a study for about four weeks with four study visits
- •able to take pancreatic enzyme medication orally
排除标准
- •significant disease other than short bowel syndrome affecting the gastrointestinal tract that impacts absorption or digestions
- •motility disorder
- •medications that directly alter fat absorption
- •cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0 mg/dL, chronic renal failure, gout, or hyperuricemia
- •history of a pork allergy
- •women who are pregnant or lactating
- •history of fibrosing colonopathy
- •Those subjects who are eligible for the malabsorption blood test (MBT) test will be excluded if they have a history of a soy or safflower oil allergy.
研究组 & 干预措施
Pancreatic Enzymes
All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.
干预措施: Pancreatic Enzyme (Drug)
结局指标
主要结局
Change in Coefficient of Fat Absorption
时间窗: Up to 10 days
Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.
次要结局
- Change in the Coefficient of Nitrogen Absorption(Up to 10 days)