NCT03018990进行中（未招募）不适用
Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- changes in concentrations of bacterial products in the liver vein
研究概览
简要总结
To investigate the effects of acute alcohol challenge on the gut and liver axis.
详细描述
To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals
- •And all of following:
- •Bodymass > 50 kg
- •Able to be fasting and abstinent on the day of intervention
- •international ratio <1.5 and platelets >100 x 10^9, 7 days before the intervention day
- •Informed consent
排除标准
- •Antibiotics during the last 4 weeks
- •Total alcohol abstinence
- •Desire of total alcohol abstinence
- •Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
- •Cirrhosis
- •Insulin dependent diabetes mellitus
- •Incapable to follow the protocol instructions
- •Pregnancy
- •Primary or secondary liver cancer
- •Severe comorbidity
- •Allergic to the contrast media iohexol
结局指标
主要结局
changes in concentrations of bacterial products in the liver vein
时间窗: Within 24 hours
次要结局
- changes in the liver metabolome, transcriptome and proteome(Within 24 hours)
- changes in the gut microbiome(Within 24 hours)
- changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system(Within 24 hours)
- changes in concentrations of bacterial products in the peripheral vein system(Within 24 hours)
研究者
Mads Israelsen
MD,clinical research assistant, PhD-student
Odense University Hospital
研究点 (2)
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