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NCT Number: NCT06519162

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

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.

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Key information

Conditions

Autoimmune Hepatitis Abdominal Abscess Abscess Autoimmune Diseases Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fatty Liver Fibrosis Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Infections Liver Abscess Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Non-Alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Biliary Cirrhosis Primary Sclerosing Cholangitis Suppuration

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospita

Daejeon, Jung-gu, 35015, South Korea

Location status: Recruiting

Location contact

HyukSoo Eun

CONTACT

[email protected]

+82 10 3470-0767

About this study

  • 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.
  • The investigators collect and analyze blood and stool samples from the patients and their household members
  • Sampling Method: Non-Probability Samples
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Individuals under the age of 19.
  • Patients or guardians who do not consent to participate in the study

Treatment and study plan

Primary outcomes

  1. Chi-square test

    Time frame: 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.

  2. t-test

    Time frame: 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.

  3. Pearson's coefficient

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyuksoo Eun

CONTACT

[email protected]

82-42-280-7418

Soon Ok Kim

CONTACT

[email protected]

82-42-280-6717

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Collaborators

  • Chungnam National University

Registry information

Official study title

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

Acronym: LGAS

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 25, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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