The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
研究概览
简要总结
Alcohol consumption is a major health problem worldwide. It affects all systems of the body especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious effects on the gastrointestinal mucosa vary from increased intestinal permeability, structural changes to sever destruction of the epithelial lining cells. Human data are still limited and most of the studies were performed in chronic alcohol abusers.
The investigators hypothesize that moderate alcohol drinking also may increase small intestinal permeability and contribute to the subsequent disruption of the tight junction complex. This study may provide more insight into the effects of moderate alcohol drinking on the small intestinal permeability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form.
- •Male gender to avoid the gender-related differences in ethanol metabolism.
- •Between 18-45 years to avoid age-related changes in ethanol metabolism
- •Normal medical history and physical examination.
- •Normal liver function tests (i.e. ALT, AST, and γGT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University Medical Center.
- •Caucasian ethnicity.
- •BMI=18 - 30 kg/m2.
排除标准
- •History of gastro-intestinal disorders or abdominal surgery.
- •History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)
- •Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
研究组 & 干预措施
alcohol
Intraduodenal infusion of ethanol
干预措施: Gastroduodenoscopy- Intraduodenal intubation (Device)
Ethanol
干预措施: Gastroduodenoscopy- Intraduodenal intubation (Device)
Placebo
Intraduodenal infusion of tap water
干预措施: Gastroduodenoscopy- Intraduodenal intubation (Device)
结局指标
主要结局
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
时间窗: 2 years
次要结局
- To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.(2 years)