Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- endotoxin
研究概览
简要总结
Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome.
So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.
详细描述
We randomly sort the participant as placebo group and colostrum group. Each group consists of 17 people. and the duration of our study for one participant is 3 weeks. (Participant takes colostrum for 3 weeks.)
When a person gets leaky gut syndrome, his or her endotoxin and lactulose/mannitol ratio (L/M ratio, in urine) can elevate.
So We will compare the value of those two parameters and LFT. etc. after the administration of colostrum or placebo.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged over 20 who's alcohol consumption per day is 20.0gram average
- •He must agree to participate this trial voluntarily.
- •Liver function test within 3 months :
- •AST more than 30 or ALT more than 33 or Gamma-GT more than 46
- •Men who have result of Ultra-sono result of abdomen without Liver cirrhosis
排除标准
- •Hepatitis B or C , liver cirrhosis patient
- •Men who have undergo bowel operation
- •Men who are taking NSAIDs
- •Periodontitis or GERD or other G-I tract infection within 2 weeks before enrollment
- •Men who have been given anticancer drug within one year
- •Men who have been given antibiotics within 2 weeks
- •Creatinine level >= 1.4mg/dl
- •Men who are taking G-I motility drugs or anti-ulcer drug
- •Milk allergy
结局指标
主要结局
endotoxin
时间窗: 1st visit and 3 weeks after 1st visit
次要结局
- lactulose/mannitol ratio(3 weeks)