Autoimmune HepatitisLGASNCT06519162
Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
An observational study of Autoimmune Hepatitis and Primary Sclerosing Cholangitis, run by Chungnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Non-Alcoholic Fatty Liver Disease
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2024to 8 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
- Exclusion
Who cannot join
- Individuals under the age of 19.
- Patients or guardians who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospita
Daejeon, Jung-gu, 35015
HyukSoo Eun, +82 10 3470-0767, hyuksoo@cnuh.co.kr
About this study
Official title: Exploration of Liver-gut Axis 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.
Read the detailed description
- 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.
- Conditions
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Non-Alcoholic Fatty Liver Disease, Liver Abscess, Primary Biliary Cirrhosis
- Keywords
- Liver Diseases, Microbiota, Immune System
- Medical subject headings
- Hepatitis, Autoimmune, Cholangitis, Sclerosing, Non-alcoholic Fatty Liver Disease, Liver Abscess, Liver Cirrhosis, Biliary, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before treatment, 3~12months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start8 Jul 2024
- Primary completion8 Jul 2029 (estimated)
- Study completion8 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chungnam National University
- Responsible party
- Principal investigator, HyukSooEun, Chungnam National University Hospital
- Investigators
- Hyuksoo Eun, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519162
- Sponsor's protocol ID
- 2024-05-009
- Acronym
- LGAS
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome
- ClinicalTrials.gov ID
- NCT06519162
- Acronym / sponsor ID
- LGAS / 2024-05-009
- Conditions
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Non-Alcoholic Fatty Liver Disease, Liver Abscess, Primary Biliary Cirrhosis
- Keywords
- Liver Diseases, Microbiota, Immune System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Collaborators
- Chungnam National University
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 8 Jul 2029 (estimated)
- Study completion
- 8 Jul 2029 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
- Exclusion
Key exclusion criteria (2 listed)
- Individuals under the age of 19.
- Patients or guardians who do not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyuksoo Eun principal investigator
Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis and Primary Sclerosing Cholangitis, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soon Ok Kim (82-42-280-6717, dona3734@cnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chi-square test (time frame: Before treatment, 3~12months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.