Gastrointestinal MicrobiomeNCT05729269
Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass
An observational study of Gastrointestinal Microbiome and Sarcopenia, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients. Read more about this study
- Who is it for?
- Ages 24 to 82 years
- Conditions the study is for
- Gastrointestinal Microbiome, Sarcopenia, Liver Disease Chronic
- What is being tested?
- Sarcopenia_CT
- How many people
- 283 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2017to 31 Dec 2021
- 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 24 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2017 to December 2019, 489 patients who agreed to collect feces among the cohort patients with chronic liver disease in five hospitals under the Hallym University Medical Center were surveyed.
Who may be able to join
- 1. Patients who have chronic liver disease (chronic liver disease cohort): alcohol liver disease, non-alcoholic liver disease, liver cirrhosis 2. Patients who consented to a study confirming the gut microbiota 3. Patients with abdominal computed tomography scan taken one month before or after submitting stool for gut microbiota analysis
Who cannot join
- Patients whose height and weight records are missing from the chart review
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Hallym University Medical College
Chuncheon, Gangwon-do, 24253
About this study
The purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients.
Read the detailed description
The effect of gut microbiota on liver disease is also well known and many studies are ongoing. A recently published study summarized the differences in the composition of gut microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty liver disease (NAFLD) progression. These changes in gut microbiota composition have been reported to affect clinical outcomes in patients by causing an increase in endotoxin, a change in bile acid metabolism, and a decrease in short chain fatty acid. In particular, the reduction of short chain fatty acid is known to be associated with the occurrence of sarcopenia. Sarcopenia, which is common in patients with cirrhosis, which is a representative chronic liver disease, is well known as a poor prognostic factor for patients. Therefore, this study aims to analyze the distribution of gut microbiota observed in patients with sarcopenia through the gut microbiota investigated in the chronic liver disease cohort patient group and the characteristics of the distribution of gut microbiota for each disease corresponding to chronic liver disease.
- Being tested
- Sarcopenia_CT
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia_CTDiagnostic test
measurement of skeletal muscle through abdominal computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease | non-alcohol liver disease, alcohol liver disease, liver cirrhosis Receives: Diagnostic Test: Sarcopenia_CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal gut microbiota between sarcopenia group and non-sarcopenia group
Compare the species and proportions of the gut microbiota between sarcopenia group and non-sarcopenia group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start22 Mar 2017
- Primary completion30 Apr 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MicrobiomeStudies 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
- Retrospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongtan Sacred Heart Hospital, Hallym University Medical Center, Hangang Sacred Heart Hospital, Kangdong Sacred Heart Hospital, Yonsei University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729269
- Sponsor's protocol ID
- microbiota_CLD-sarcopenia
- Status last verified
- Apr 2021
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass
- ClinicalTrials.gov ID
- NCT05729269
- Acronym / sponsor ID
- microbiota_CLD-sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Dongtan Sacred Heart Hospital, Hallym University Medical Center, Hangang Sacred Heart Hospital, Kangdong Sacred Heart Hospital, Yonsei University
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Feb 2023 (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.
The purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients.
Detailed description
The effect of gut microbiota on liver disease is also well known and many studies are ongoing. A recently published study summarized the differences in the composition of gut microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty liver disease (NAFLD) progression. These changes in gut microbiota composition have been reported to affect clinical outcomes in patients by causing an increase in endotoxin, a change in bile acid metabolism, and a decrease in short chain fatty acid. In particular, the reduction of short chain fatty acid is known to be associated with the occurrence of sarcopenia. Sarcopenia, which is common in patients with cirrhosis, which is a representative chronic liver disease, is well known as a poor prognostic factor for patients. Therefore, this study aims to analyze the distribution of gut microbiota observed in patients with sarcopenia through the gut microbiota investigated in the chronic liver disease cohort patient group and the characteristics of the distribution of gut microbiota for each disease corresponding to chronic liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease | – | Diagnostic Test: Sarcopenia_CTnon-alcohol liver disease, alcohol liver disease, liver cirrhosis |
Who may qualify
- Ages
- 24 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2017 to December 2019, 489 patients who agreed to collect feces among the cohort patients with chronic liver disease in five hospitals under the Hallym University Medical Center were surveyed.
Key inclusion criteria (1 listed)
- 1. Patients who have chronic liver disease (chronic liver disease cohort): alcohol liver disease, non-alcoholic liver disease, liver cirrhosis 2. Patients who consented to a study confirming the gut microbiota 3. Patients with abdominal computed tomography scan taken one month before or after submitting stool for gut microbiota analysis
Key exclusion criteria (1 listed)
- Patients whose height and weight records are missing from the chart review
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 |
|---|---|---|
| Sarcopenia_CTmeasurement of skeletal muscle through abdominal computed tomography | Diagnostic test | Chronic liver disease |
Primary outcome
Fecal gut microbiota between sarcopenia group and non-sarcopenia group
Time frame: 2 years
Compare the species and proportions of the gut microbiota between sarcopenia group and non-sarcopenia group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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 Gastrointestinal Microbiome and Sarcopenia, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 gut microbiota between sarcopenia group and non-sarcopenia group (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.