Liver Disease ChronicNCT04339725
Gut Microbiota Metagenomics for Chronic Liver Disease
An observational study of Liver Disease Chronic, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Gut microbiota modulation has effect on chronic liver disease Read more about this study
- Who is it for?
- Ages 31 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease Chronic
- What is being tested?
- DNA extraction
- How many people
- 3,240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2017to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3240 of population stool were collected. All of them are agree to provide it to investigation.
Who may be able to join
- 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)
Who cannot join
- Normal : AST or ATL level ≥ 50IU/L, BMI ≥ 25
- Liver disease : AST or ALT level < 50IU/L, BMI < 25
- If the patient refuses
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 200-704
About this study
Official title: Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease
Gut microbiota modulation has effect on chronic liver disease
Read the 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.
- Conditions
- Liver Disease Chronic
- Being tested
- DNA extraction
- Keywords
- Liver, Fecal, Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extractionOther
Extraction fecal DNA and compare disease group to normal group
| Study group | Role | What they receive |
|---|---|---|
| Fecal DNA | Extraction fecal DNA and compare disease group to normal group Receives: Other: DNA extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal DNA
Compare the species and proportions of the gut microbiome
Measured: 10 years
Liver enzyme
Compare the liver enzyme level
Measured: 10 years
BMI
Compare the body mass index
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Apr 2017
- Primary completion1 Mar 2020
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339725
- Sponsor's protocol ID
- STOOL
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38997279Ganesan 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.
PubMed 37000389
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Based on Gut Microbiota Metagenomics for Prevention of Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04339725
- Acronym / sponsor ID
- STOOL
- Conditions
- Liver Disease Chronic
- Keywords
- Liver, Fecal, Gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,240 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gut microbiota modulation has effect on chronic liver disease
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal DNA | – | Other: DNA extractionExtraction fecal DNA and compare disease group to normal group |
Who may qualify
- Ages
- 31 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3240 of population stool were collected. All of them are agree to provide it to investigation.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Normal : AST or ATL level ≥ 50IU/L, BMI ≥ 25
- Liver disease : AST or ALT level < 50IU/L, BMI < 25
- If the patient refuses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extractionExtraction fecal DNA and compare disease group to normal group | Other | Fecal DNA |
Primary outcome
Fecal DNA
Time frame: 10 years
Compare the species and proportions of the gut microbiome
Liver enzyme
Time frame: 10 years
Compare the liver enzyme level
BMI
Time frame: 10 years
Compare the body mass index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 38997279Park 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.
- Derived from this study: PubMed 37000389Ganesan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease Chronic, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal DNA (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.