Gut Microbiota Metagenomics for Chronic Liver Disease

Liver Disease Chronic Clinical Trial

Official title:

Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04339725
• Other study ID #: STOOL
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gut microbiota modulation has effect on chronic liver disease

Description:

Chronic liver disease has been known as a disease of the liver which lasts over a period of 6-month. It consists of inflammation, hepatitis, cirrhosis, hepatocellular carcinoma.

Gut microbiota plays an important roles in the chronic liver disease. It can suppress the progression of the liver disease by moulation gut microbiota.

The investigators are still evaluating the effect of gut microbiota on the liver disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3240
• Est. completion date: January 1, 2025
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 82 Years

Eligibility

Inclusion Criteria:

• Age 19+

• Normal : AST or ALT level < 50IU/L, BMI < 25

• Liver disease : AST or ATL level = 50IU/L, BMI = 25

• Patients hospitalized with chronic liver disease (viral hepatitis, alcoholic liver disease, non-alcoholic liver disease, cirrhosis, liver cancer)

Exclusion Criteria:

• Normal : AST or ATL level = 50IU/L, BMI = 25

• Liver disease : AST or ALT level < 50IU/L, BMI < 25

• If the patient refuses

Related Conditions & MeSH terms

• Liver Disease Chronic
• Liver Diseases

Intervention

Other:
• DNA extraction
Extraction fecal DNA and compare disease group to normal group

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital	Chuncheon

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal DNA	Compare the species and proportions of the gut microbiome	10 years
Primary	Liver enzyme	Compare the liver enzyme level	10 years
Primary	BMI	Compare the body mass index	10 years