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

NCT ID: NCT06519162

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-08

Study Completion Date

2029-07-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chungnam National University

OTHER

Sponsor Role collaborator

Chungnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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HyukSooEun

Associate Professor of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyuksoo Eun

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

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Chungnam National University Hospita

Daejeon, Jung-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soon Ok Kim

Role: CONTACT

82-42-280-6717

Hyuksoo Eun

Role: CONTACT

82-42-280-7418

Facility Contacts

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HyukSoo Eun

Role: primary

+82 10 3470-0767

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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2024-05-009

Identifier Type: -

Identifier Source: org_study_id

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