Clinical trial NCT06519162: Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
Official title: Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Hepatitis
Primary Sclerosing Cholangitis
Non-Alcoholic Fatty Liver Disease
Liver Abscess
Primary Biliary Cirrhosis
Keywords: Liver Diseases
Microbiota
Immune System
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chungnam National University
First posted: 2024-07-25
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chi-square test
timeFrame: Before treatment, 3~12months after treatment
measure: t-test
timeFrame: Before treatment, 3~12months after treatment
measure: Pearson's coefficient
timeFrame: Before treatment, 3~12months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospita
state: Jung-gu
Study officials:
affiliation: Chungnam National University Hospital
name: Hyuksoo Eun
role: PRINCIPAL_INVESTIGATOR
References: