Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.

Detailed Description
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Stool samples were collected prospectively from 240 participants (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). 16S rRNA (ribosomal ribonucleic acid) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship,16S-based Microbiome Taxonomic Profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.

Official Title
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Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis

Conditions
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Liver Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered in the Hallym University Hospital Presented initially sign of liver cirrhosis Patients must have the following laboratory parameters at screening: Alanine aminotransferase (ALT) ≤10 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤10 × ULN Hemoglobin ≥12 g/dL for male, ≥11 g/dL for female patients Platelets ≥ 50,000/mm3 International normalized ratio (INR) ≤1.5 × ULN unless patient has known haemophilia or is stable on an anticoagulant regimen affecting INR. Albumin ≥3g/dL. 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: Pregnant Female
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Control<br>Total number of 52 Healthy Control Included in the study | |
| Alcoholic Control<br>Total number of 46 Alcoholic Control Included in the study | |
| Only Cirrhosis<br>Total 10 patients with only cirrhosis (n= 10, age 66.66±13.51 years) are included in this study | |
| Cirrhosis+ HCC<br>Total 26 patients with Cirrhosis+ hepatocellular carcinoma (HCC) (n= 26, age 61.61±9.85 years) are included in this study | |
| Cirrhosis+ Varices<br>Total 7 patients with Cirrhosis+ Varices (n= 7, age 48.42±15.80 years) are included in this study | |
| Cirrhosis+ Ascites<br>Total number of 26 patients with Cirrhosis+ Ascites (n= 26, age 55.96±8.51years) are included in this study | |
| Cirrhosis+ 2 Complications<br>Total number of 44 patients with cirrhosis with 2 complications (n=44, age 57.84±9.18 years) are included in this study | |
| Cirrhosis+ 3 Complications<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications. | Gut microbial biomarkers, such as bacterial DNA and metabolic products in the feces, can provide valuable information about the gut microbiome in patients with decompensated cirrhosis, and may be useful in predicting the risk of complications and monitoring disease progression. However, more research is needed to fully understand the role of gut microbiota in decompensated cirrhosis and its complications, and to determine the utility of gut microbial biomarkers as a diagnostic or therapeutic tool in liver cirrhosis and cirrhosis with complications. Therefore, in this clinical trial the investigator will identify cirrhosis dependent bacterial species and metabolites which can have the ability to replace the invasive clinical biomarker for early detection of decompensation in cirrhosis. | 2 years |