The Role of the Intestinal Barrier Function in Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test
研究概览
简要总结
Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.
The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis of any cause
- •A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
- •Age between 18 and 65 years
排除标准
- •Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
- •Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)
结局指标
主要结局
The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test
时间窗: 2 years
次要结局
- To assess tight junction structure and proteins in biopsy specimens of small and large intestine(2 years)