Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
研究概览
简要总结
The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown.
详细描述
In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo, with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.
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
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female
- •Age ≥ 18 years but < 45 years
- •Hormonal contraceptive treatment
- •Subject has read and understood the information provided on the study and given written informed consent
排除标准
- •Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
- •pregnancy or lactation
- •women not treated with hormonal contraceptive treatment
结局指标
主要结局
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
时间窗: 0-240 min
Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum
次要结局
- Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach(0-240 min)
- Effect of meal caloric density on gastric emptying(0-240 min)
- Effect of AN-PEP and meal caloric density on gastric and duodenal pH(0-240 min)
- Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum(0-240 min)
- Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach(0-240 min)