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

Chuncheon Sacred Heart Hospital

Status: Completed

Conditions: Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT05786755

Liver cirrhosis, gut microbime

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Registered in the Hallym University Hospital

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:

   • Pregnant Female

Trial design

3,000 participants in 8 patient groups

Healthy Control

Description:

Total number of 52 Healthy Control Included in the study

Alcoholic Control

Description:

Total number of 46 Alcoholic Control Included in the study

Only Cirrhosis

Description:

Total 10 patients with only cirrhosis (n= 10, age 66.66±13.51 years) are included in this study

Cirrhosis+ HCC

Description:

Total 26 patients with Cirrhosis+ hepatocellular carcinoma (HCC) (n= 26, age 61.61±9.85 years) are included in this study

Cirrhosis+ Varices

Description:

Total 7 patients with Cirrhosis+ Varices (n= 7, age 48.42±15.80 years) are included in this study

Cirrhosis+ Ascites

Description:

Total number of 26 patients with Cirrhosis+ Ascites (n= 26, age 55.96±8.51years) are included in this study

Cirrhosis+ 2 Complications

Description:

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

Description:

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