Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Effect of 160.000 PPI AN-PEP on duodenal gluten
研究概览
简要总结
In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female
- •Age ≥18 but <70 yr
- •Females: Hormonal contraceptive treatment
- •Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
- •Subject has read and understood the information provided on the study and given written informed consent
排除标准
- •Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
- •Wheat allergy (serological test for wheat protein IgE antibodies)
- •Medication or medical condition that affects gastric emptying or secretion
- •Females: Pregnancy or breast-feeding
- •Inability to swallow the gastroduodenal feeding tube
- •Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
- •Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
结局指标
主要结局
Effect of 160.000 PPI AN-PEP on duodenal gluten
时间窗: 3-hour
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
次要结局
- Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction(3-hour)
- Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction(3-hour)
- Effect of 160.000 PPI AN-PEP on gastric gluten(3-hour)
- Effect of 80.000 PPI AN-PEP on duodenal gluten(3-hour)
- Effect of 80.000 PPI AN-PEP on gastric gluten AUC(3-hour)
- Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction(3-hour)
- Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction(3-hour)
研究者
Robert Brummer
Prof
Örebro University, Sweden