Gut Microbiota Metagenomics for Chronic Liver Disease

April 7, 2020 updated by: Ki Tae Suk, Chuncheon Sacred Heart Hospital

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

Gut microbiota modulation has effect on chronic liver disease

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of, 200-704
        • Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3240 of population stool were collected. All of them are agree to provide it to investigation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fecal DNA
Extraction fecal DNA and compare disease group to normal group
Other: DNA extraction
Extraction fecal DNA and compare disease group to normal group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 10 years
Compare the body mass index
10 years
Fecal DNA
Time Frame: 10 years
Compare the species and proportions of the gut microbiome
10 years
Liver enzyme
Time Frame: 10 years
Compare the liver enzyme level
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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