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临床试验/NCT04260503
NCT04260503Unknown不适用

Analysis of Gut Microbiome and Liver Imaging Including Elasticity in Biliary Atresia Patients With Cholangitis for the Prediction of Disease Activity and Improvement of Outcome Using Fecal Microbiota Transplantation

Yonsei University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年5月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
The changes of gut-microbiome according to the disease.

研究概览

简要总结

The investigator will investigate the gut-microbiome and liver elasticity of the Biliary Atresia (BA)-patients before and after Kasai operation. The data will be analyzed according to their clinical outcomes including cholangitis to find out diagnostic makers, significantly associated with the BA-phenotypes. The decision-making tree for the BA will be updated with our data, which will strength the prognosis and prediction. The establishment of gut-liver axis, featured by cholangitis and gut-microbiome will open new pathway to treat the BA using fecal microbiota transplantation.

  1. Analysis of gut-microbiome: The investigator will investigate the alteration of gut-microbiome by restoration of bile flow at diagnosis, before and after Kasai procedure. In case of cholangitis after Kasai operation, signature gut-microbiome will be analyzed, which will lead to prevention of BA-patients from cholangitis via the bacteria transplantation.
  2. Analysis of elastography: In order to improve non-invasive diagnosis, The investigator will investigate the alteration of liver elasticity and hepatic blood flow before and after Kasai procedure as well as upon cholangitis and choledochal cyst. Those data will be analyzed in parallel with serum biochemical markers to be associated with pathophysiological events e.g., cholestasis, cholangitis and fibrosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 0-4 months old
  • Patients, diagnosed with the BA and scheduled for Kasai operation during our study period
  • Patients whose parents or guardian understand our research aims, and comply to participate in our researches

排除标准

  • Patients, whose diagnosis of BA was not definite.
  • Patients, scheduled for Kasai operation after 4 months old
  • Choledochal cyst (Disease control)
  • Inclusion Criteria:
  • 0-7 years old
  • Patients, diagnosed with choledochal cyst and scheduled for total cyst removal during our study period
  • Patients whose parents or guardian understand our research aims, and comply to participate in our researches
  • Exclusion Criteria:
  • Patients, whose diagnosis of choledochal cysts was not definite.
  • Patients with choledochal cyst, but greater than 7 years old
  • Neonatal hepatitis (Disease control)
  • Inclusion Criteria:
  • 0-4 months old
  • Patients, diagnosed with the neonatal hepatitis during our study period
  • Patients whose parents or guardian understand our research aims, and comply to participate in our researches
  • Exclusion Criteria:
  • Patients with hepatobiliary infection
  • Patients, required to use antibiotics to treat the infection
  • Patients with hepatobiliary inflammation, caused by abnormal intra- or extra-hepatic structure
  • Healthy control
  • Inclusion Criteria:
  • 0-4 months old
  • Healthy neonates without chronic diseases when they visit for vaccination
  • Healthy neonates whose parents or guardian understand our research aims, and comply to participate in our researches
  • Exclusion Criteria:
  • Patients with hepatobiliary infection
  • Patients, required to use antibiotics to treat the infection
  • Neonates with less than 37 weeks (i.e., preterm) or hospitalized in neonatal intensive care unit
  • Patients, diagnosed with congenital malformation, syndrome and chronic diseases

结局指标

主要结局

The changes of gut-microbiome according to the disease.

时间窗: 1year

Using shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes.

次要结局

  • Comparison of gut microbiome according to the clinical outcomes of biliary atresia.(1year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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