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

NCT06519162 | Recruiting

• 1 other identifier: 2024-05-009
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Hepatitis; Primary Sclerosing Cholangitis; Non-Alcoholic Fatty Liver Disease; Liver Abscess; Primary Biliary Cirrhosis

Keywords

Liver Diseases; Microbiota; Immune System

Outcome Measures

Primary Outcomes (3)

• Chi-square test

  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.

  Before treatment, 3~12months after treatment

• t-test

  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.

  Before treatment, 3~12months after treatment

• Pearson's coefficient

  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.

  Before treatment, 3~12months after treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients( Autoimmune liver diseases (Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis), Metabolic liver diseases (Non-alcoholic fatty liver disease) Infectious liver diseases (Liver abscess) \- their cohabitant

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chungnam National University Hospital: lead
• Chungnam National University: collaborator

Study Sites (1)

Chungnam National University Hospita

Daejeon, Jung-gu, 35015, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous whole blood and or Stool

MeSH Terms

Conditions

Hepatitis, Autoimmune; Cholangitis, Sclerosing; Non-alcoholic Fatty Liver Disease; Liver Abscess; Liver Cirrhosis, Biliary; Liver Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyuksoo Eun

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soon Ok Kim

CONTACT

82-42-280-6717; dona3734@cnuh.co.kr

Hyuksoo Eun

CONTACT

82-42-280-7418; hyuksoo@cnuh.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 25, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): July 8, 2029
• Study Completion (Estimated): July 8, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

KR (1)