Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT02485106
Eligibility Criteria:
Inclusion Criteria:
* Heavy alcohol drinking within 3 months (Over 40 g/day)
* Maddrey's discriminant function ≥ 32
* AST/ALT ration ≥ 2
* Bilirubin level ≥ 5mg/dL
* Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
* Age : 19-75
* Jaundice within 3 months
Exclusion Criteria:
* Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
* Antibiotics or probiotics use within 8 weeks
* Drug induced hepatotoxicity
* Acute viral hepatitis (HAV or HEV)
* Hepatic abscess or cholagitis
* Hepatocellular carcinoma of modified UICC stage II, III or IV
* Malignant tumor other than HCC
* Pregnancy
* Severe chronic extrahepatic disease
* Type I hepatorenal syndrome
* Hepatic encephalopathy grade II or IV
* Severe infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT02485106
Study Brief:
Protocol Section:
NCT02485106