Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment
研究概览
简要总结
Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coeliac disease and having chronic diarrhoea (>3 loose/ liquid motions a day for more than 4 weeks)
- •Patients with a low faecal elastase (<200 ug/g),
- •Patients aged 16 years or over
- •Patient able to give written consent to participate
- •Patient not currently on Creon
排除标准
- •Patients with normal faecal elastase (> 201ug/g),
- •Patients under the age of 16
- •Patients allergic to pork or any pig product (advice from the drug manufacturer)
- •Patients that are pregnant or are breast-feeding
- •Patients taking alternative medication that could affect bowel frequency
- •Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial
- •Patients who are unable to speak or understand English
研究组 & 干预措施
Placebo
Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.
干预措施: Placebo (Other)
Creon
Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.
干预措施: Creon (Drug)
结局指标
主要结局
Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment
时间窗: 6 weeks
次要结局
- Quality of life(6 weeks)
- body mass index(6 weeks)