Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fecal Fat percentage
研究概览
简要总结
Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the treatment to be effective. In addition, consultation of a specialized dietician is pivotal to educate patients about the proper use of pancreatic enzymes. However, based on a recent prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.
详细描述
This is a prospective, open, comparative study with a linear design with two sequential phases (observatory, then patient-monitored).
The research population consists of patients who are treated with pancreatic enzymes (< 6 capsules p/d containing 25,000 units of lipase) for exocrine insufficiency caused by chronic pancreatitis.
After inclusion, patients will discontinue taking pancreatic enzymes during one week (wash-out period). The last four days of this week, a fecal fat balance test will be performed to quantify the fecal fat loss without enzyme correction. If the fecal fat excretion is less than 15%, this is considered normal and therefore the patient will be excluded from the study. Subsequently, the next three weeks of the trial the patient will restart using the same dose of pancreatic enzymes the way it was prescribed before inclusion. The last four days of the fourth week, a fecal fat balance test will be repeated to quantify the fecal fat loss with enzyme correction. After this test the intervention takes place, consisting of a standardised education of the patient by a dietician. In the second phase of four weeks, patients are stimulated to use this information to self-dose the amount of pancreatic enzymes according to the fat content of their diet. In the last week of the study a fecal fat balance test will be repeated.
The primary endpoint is the fecal fat excretion. Secondary endpoints are the change in enzyme dose after intervention, improvement of complaints (e.g. steatorrhoea related complaints, abdominal cramps, abdominal pain), change in dietary habits, patient satisfaction, quality of life, evaluation of the nutritional status, and the occurrence of side effects.
Because the maximum amount of 16 capsules of pancreatic enzymes a day according to the standard guidelines will not be exceeded in this trial, no risks are foreseen. The anticipated benefit of the study is that patients will be treated more effectively for their EPI. The burden of this trial for patients is the repeated fecal fat balance test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years.
- •EPI caused by CP.
- •Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day).
- •Fecal elastase < 0.200 mg/g
- •fecal fat-absorption < 85% without using enzymes.
排除标准
- •Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.
- •Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat
- •Gastroparesis of any aetiology
- •Hypersensitivity to pork protein
- •Acute pancreatitis
- •Limited life-expectancy of ≤ 6 months
- •Malignancy of the pancreas
- •Pregnancy/lactation
研究组 & 干预措施
Panzytrat fixed dose vs. self-dosing
In Phase I (week 1-4) patients will use the fixed amount of lipase as was prescribed by their treating physician. Phase II (week 5-9) patients will start the self-dosage regimen with pancreatic enzymes (without exceeding the maximum amount of 16 capsules per day). They are properly educated by the researcher and dietician how to adjust the amount of pancreatic enzymes to the fat intake in their diet.
干预措施: Panzytrat 25.000 FIP-E units of Lipase (Drug)
结局指标
主要结局
Fecal Fat percentage
时间窗: week 1, 5 and 9
difference in efficacy measured by the fecal fat content during treatment with pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI due to chronic pancreatitis
次要结局
- enzyme dose(On a weekly base during 9 weeks)
- Improvement of steatorrhea-related complaints(On a weekly base during 9 weeks)
- Change in dietary habits(Week 1, 5 and 9)
- Patient satisfaction(Week 4 and 9)
- Quality of life(week 4 and 9)
- Evaluation of the nutritional status(week 5 and 9)