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

NCT05786755 | Completed DMC

• 1 other identifier: Liver cirrhosis, gut microbime
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

Healthy Control

Total number of 52 Healthy Control Included in the study

Alcoholic Control

Total number of 46 Alcoholic Control Included in the study

Only Cirrhosis

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

Cirrhosis+ HCC

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

Cirrhosis+ Varices

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

Cirrhosis+ Ascites

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

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

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Microbiome Taxonomic Profiling was performed on 240 stool samples (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). All 142 patients were classified in six groups based on compilation: only cirrhosis, cirrhosis with hepatocellular carcinoma (HCC), cirrhosis with varices, cirrhosis with ascites, cirrhosis with 2 complications and cirrhosis with 3 or more complication.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant Female

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 200-704, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ki Tae Suk, PhD

  Chuncheon Sacred Hallym hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 28, 2023
• Study Start: August 15, 2018
• Primary Completion: June 15, 2021
• Study Completion: July 10, 2021
• Last Updated: March 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)