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临床试验/NCT06519162
NCT06519162招募中不适用

Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome

Chungnam National University Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Chi-square test

研究概览

简要总结

In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.

详细描述

  1. The investigators will recruit study participants aged 19 and older who have been diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or liver abscess, along with their household members, and who have agreed to participate in this study at Chungnam National University Hospital.
  2. The investigators collect and analyze blood and stool samples from the patients and their household members
  3. Sampling Method: Non-Probability Samples
  4. Study Population:

Group of autoimmune hepatitis: patients with definite autoimmune hepatitis or their healthy households for controls Group of primary biliary cholangitis: patients with definite primary biliary cholangitis or their healthy households for controls Group of primary sclerosing cholangitis: patients with definite primary sclerosing cholangitis or their healthy households for controls Group of non-alcoholic steatohepatitis: patients with definite non-alcoholic steatohepatitis or their healthy households for controls Group of liver abscess: patients with definite liver abscess or their healthy households for controls.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years and older diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, who have consented to participate in this study at Chungnam National University Hospital.
  • Adults aged 19 years and older, who are cohabitants of patients diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, and have consented to participate in this study at Chungnam National University Hospital.
  • B. Exclusion

排除标准

  • Individuals under the age of
  • Patients or guardians who do not consent to participate in the study

结局指标

主要结局

Chi-square test

时间窗: Before treatment, 3~12months after treatment

Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis ) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases.

t-test

时间窗: Before treatment, 3~12months after treatment

Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases.

Pearson's coefficient

时间窗: Before treatment, 3~12months after treatment

Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases.

次要结局

未报告次要终点

研究者

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

HyukSooEun

Associate Professor of Gastroenterology

Chungnam National University Hospital

研究点 (1)

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