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

Completed

• Conditions: Liver Cirrhosis

• Registration Number: NCT05786755
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2021-06-15
• Study Completion: 2021-07-10
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications.	2 years	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwondo, Korea, Republic of