- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04339725
Gut Microbiota Metagenomics for Chronic Liver Disease
Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Chuncheon, Korea, Republic of, 200-704
- Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
Extraction fecal DNA and compare disease group to normal group
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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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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