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临床试验/NCT02808663
NCT02808663已完成不适用

Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

CHU de Reims2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
6
试验地点
2
主要终点
fecal calprotectin concentration

研究概览

简要总结

Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like interleukin-8 (IL-8).

Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated.

The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and predictive of infections.

详细描述

Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like IL-8.

Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated.

The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of LPS binding protein and predictive of infections.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with severe alcoholic hepatitis defined by a "Maddrey discriminant function" above 32
  • histological confirmation of the diagnosis and indication for corticotherapy
  • signed written informed consent and social security affiliation

排除标准

  • age below 18
  • pregnant or breastfeeding women
  • history of intestinal disease, digestive haemorrhage
  • treatment with antibiotics, NSAIDs or proton pump inhibitors during the month before inclusion
  • patient under guardianship

研究组 & 干预措施

Severe Alcoholic Hepatitis

Experimental

干预措施: fecal calprotectin concentration (Biological)

Severe Alcoholic Hepatitis

Experimental

干预措施: blood collection (Biological)

结局指标

主要结局

fecal calprotectin concentration

时间窗: Day7

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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