Gut Microbiota Metagenomics for Chronic Liver Disease

• Sponsor: Chuncheon Sacred Heart Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04339725
• Collaborator: (none)
• Enrollment: 3,240
• Location: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 34.8

Study Details

Study Description

Brief Summary

Gut microbiota modulation has effect on chronic liver disease

Condition or Disease	Intervention/Treatment	Phase
Liver Disease Chronic	Other: DNA extraction

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 Design

• Study Type: Observational
• Actual Enrollment: 3240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Fecal DNA [10 years]

   Compare the species and proportions of the gut microbiome

2. Liver enzyme [10 years]

   Compare the liver enzyme level

3. BMI [10 years]

   Compare the body mass index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 31 Years to 82 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital	Chuncheon		Korea, Republic of	200-704

Sponsors and Collaborators

• Chuncheon Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ki Tae Suk, Proffesor, Chuncheon Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT04339725
• Other Study ID Numbers: STOOL
• First Posted: Apr 9, 2020
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ki Tae Suk, Proffesor, Chuncheon Sacred Heart Hospital: Liver; Fecal; Gut microbiota
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Apr 9, 2020