NCT04339725

Brief Summary

Gut microbiota modulation has effect on chronic liver disease

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 7, 2020

Last Update Submit

April 7, 2020

Conditions

Liver Disease Chronic

Keywords

LiverFecalGut microbiota

Outcome Measures

Primary Outcomes (3)

  • Fecal DNA

    Compare the species and proportions of the gut microbiome

    10 years

  • Liver enzyme

    Compare the liver enzyme level

    10 years

  • BMI

    Compare the body mass index

    10 years

Study Arms (1)

Fecal DNA

Extraction fecal DNA and compare disease group to normal group

Other: DNA extraction

Interventions

DNA extractionOTHER

Extraction fecal DNA and compare disease group to normal group

Fecal DNA

Eligibility Criteria

Age31 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Normal : AST or ATL level ≥ 50IU/L, BMI ≥ 25
  • Liver disease : AST or ALT level \< 50IU/L, BMI \< 25
  • If the patient refuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 200-704, South Korea

Location

Related Publications (2)

  • Park IG, Yoon SJ, Won SM, Oh KK, Hyun JY, Suk KT, Lee U. Gut microbiota-based machine-learning signature for the diagnosis of alcohol-associated and metabolic dysfunction-associated steatotic liver disease. Sci Rep. 2024 Jul 12;14(1):16122. doi: 10.1038/s41598-024-60768-2.

    PMID: 38997279DERIVED

  • Ganesan R, Gupta H, Jeong JJ, Sharma SP, Won SM, Oh KK, Yoon SJ, Han SH, Yang YJ, Baik GH, Bang CS, Kim DJ, Suk KT. Characteristics of microbiome-derived metabolomics according to the progression of alcoholic liver disease. Hepatol Int. 2024 Apr;18(2):486-499. doi: 10.1007/s12072-023-10518-9. Epub 2023 Mar 31.

    PMID: 37000389DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 9, 2020

Study Start

April 1, 2017

Primary Completion

March 1, 2020

Study Completion

January 1, 2025

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)