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临床试验/NCT04195724
NCT04195724Unknown不适用

Microbiome Translocation in Different Circulatory Compartments in Decompensated Cirrhosis

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
The circulating microbiome in ascites,fecal and in blood of different circulatory compartments (superior mesenteric vein, peripheral vein and hepatic vein, respectively).

研究概览

简要总结

Acquired dysfunctional immunity in cirrhosis predisposes patients to frequent bacterial infections contributing to disease progression and may lead to the development of acute-on-chronic liver failure (ACLF). Spontaneous bacterial peritonitis (SBP) is one of the most frequent infections in cirrhosis and therefore a trigger for ACLF. ACLF is characterized by systemic inflammation even in the absence of confirmed infection and associated with poor outcome. The source of ascites infection, especially in case of culture-positive SBP and bacterascites, is suspected to be bacterial translocation from gut.

In decompensated cirrhosis, data on the gut microbial translocation in different circulatory compartments is limited. Moreover, the link between gut microbiome and systemic inflammation in liver disease has still not established.

The transjugular intrahepatic portosystemic shunt (TIPS) is applied to treat portal hypertension which frequently leads to intestinal bleeding, life-threatening esophageal bleeding and ascites. Under the procedure of TIPS, the vein blood samples in different compartments (superior mesenteric vein, portal vein and hepatic vein) from patients with decompensated liver cirrhosis are available. Metagenomic next-generation sequencing (mNGS) is a promise approach for the diagnosis of infectious disease because a comprehensive spectrum of potential causes (viral, bacterial, fungal, and parasitic) can be identified by a single assay. Previous study reported that mNGS of cerebrospinal fluid can be applied to diagnosis of meningitis and encephalitis. Comparing to traditional bacterial culture method, mNGS method is more sensitive and rapidly in pathogen detection. Therefore, the circulating microbiome in different compartment can be characterized by means of mNGS.

Here, the study aim to investigate the circulating microbiome from superior mesenteric vein (first venous outflow in gut-liver axis), hepatic vein (liver outflow), peripheral vein and ascites from patients with decompensated liver cirrhosis receiving TIPS. Before TIPS, fecal sample and unary sample are collected. And mNGS method is performed to identify the pathogen in ascites,fecal and blood samples in a single center. Ultimately, the study aim to build up the link between gut microbiome translocation and liver disease.

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

  • Age>18 years old;
  • Patients with decompensated liver cirrhosis;
  • Patients receiving TIPS for either variceal bleeding or refractory ascites.

排除标准

  • Hepatic tumor or extrahepatic related cancer;
  • Not provide written consent.

结局指标

主要结局

The circulating microbiome in ascites,fecal and in blood of different circulatory compartments (superior mesenteric vein, peripheral vein and hepatic vein, respectively).

时间窗: 28 days

mNGS and metabonomics are performed in ascites,fecal and in blood of different circulatory compartments (superior mesenteric vein, peripheral vein and hepatic vein, respectively).

次要结局

  • The improvement of gut microbiome translocation 6 months after the operation of TIPS.(6 months after discharge)
  • The occurrence of decompensated events (infection, ascites, hepatic encephalopathy, gastrointestinal bleeding) 1 year after the operation of TIPS.(1 years after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinjun Chen

Hepatology Unit, Department of Infectious Diseases

Nanfang Hospital, Southern Medical University

研究点 (1)

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