Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis
NCT ID: NCT05786755
Last Updated: 2023-03-28
Study Results
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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COMPLETED
3000 participants
OBSERVATIONAL
2018-08-15
2021-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Healthy Control
Total number of 52 Healthy Control Included in the study
No interventions assigned to this group
Alcoholic Control
Total number of 46 Alcoholic Control Included in the study
No interventions assigned to this group
Only Cirrhosis
Total 10 patients with only cirrhosis (n= 10, age 66.66±13.51 years) are included in this study
No interventions assigned to this group
Cirrhosis+ HCC
Total 26 patients with Cirrhosis+ hepatocellular carcinoma (HCC) (n= 26, age 61.61±9.85 years) are included in this study
No interventions assigned to this group
Cirrhosis+ Varices
Total 7 patients with Cirrhosis+ Varices (n= 7, age 48.42±15.80 years) are included in this study
No interventions assigned to this group
Cirrhosis+ Ascites
Total number of 26 patients with Cirrhosis+ Ascites (n= 26, age 55.96±8.51years) are included in this study
No interventions assigned to this group
Cirrhosis+ 2 Complications
Total number of 44 patients with cirrhosis with 2 complications (n=44, age 57.84±9.18 years) are included in this study
No interventions assigned to this group
Cirrhosis+ 3 Complications
Total number of 29 patients with cirrhosis and 3 or more complication (n=29, aged 59.64±12.61 years) are included in this study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Presented initially sign of liver cirrhosis
3. Patients must have the following laboratory parameters at screening:
1. Alanine aminotransferase (ALT) ≤10 × upper limit of normal (ULN)
2. Aspartate aminotransferase (AST) ≤10 × ULN
3. Hemoglobin ≥12 g/dL for male, ≥11 g/dL for female patients
4. Platelets ≥ 50,000/mm3
5. International normalized ratio (INR) ≤1.5 × ULN unless patient has known haemophilia or is stable on an anticoagulant regimen affecting INR.
6. Albumin ≥3g/dL.
7. Direct bilirubin ≤1.5 × ULN h) HbA1c ≤10.0%
i) Creatinine clearance (CLcr) ≥60 mL/min, as calculated by the Cockcroft-Gault equation.
\-
Exclusion Criteria
ALL
No
Sponsors
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Chuncheon Sacred Heart Hospital
OTHER
Responsible Party
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Principal Investigators
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Ki Tae Suk, PhD
Role: PRINCIPAL_INVESTIGATOR
Chuncheon Sacred Hallym hospital
Locations
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Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, South Korea
Countries
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Other Identifiers
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Liver cirrhosis, gut microbime
Identifier Type: -
Identifier Source: org_study_id
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