Liver CirrhosisNCT05786755
Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Aug 2018to 10 Jul 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Microbiome Taxonomic Profiling was performed on 240 stool samples (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). All 142 patients were classified in six groups based on compilation: only cirrhosis, cirrhosis with hepatocellular carcinoma (HCC), cirrhosis with varices, cirrhosis with ascites, cirrhosis with 2 complications and cirrhosis with 3 or more complication.
Who may be able to join
- Registered in the Hallym University Hospital
- Presented initially sign of liver cirrhosis
- Patients must have the following laboratory parameters at screening:
- Alanine aminotransferase (ALT) ≤10 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤10 × ULN
- Hemoglobin ≥12 g/dL for male, ≥11 g/dL for female patients
Show all 12Show fewer
- Platelets ≥ 50,000/mm3
- International normalized ratio (INR) ≤1.5 × ULN unless patient has known haemophilia or is stable on an anticoagulant regimen affecting INR.
- Albumin ≥3g/dL.
- Direct bilirubin ≤1.5 × ULN h) HbA1c ≤10.0%
- Creatinine clearance (CLcr) ≥60 mL/min, as calculated by the Cockcroft-Gault equation.
- -
Who cannot join
- Pregnant Female
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, 200-704
About this study
Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.
Read the detailed description
Stool samples were collected prospectively from 240 participants (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). 16S rRNA (ribosomal ribonucleic acid) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship,16S-based Microbiome Taxonomic Profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Total number of 52 Healthy Control Included in the study | |
| Alcoholic Control | Total number of 46 Alcoholic Control Included in the study | |
| Only Cirrhosis | Total 10 patients with only cirrhosis (n= 10, age 66.66±13.51 years) are included in this study | |
| Cirrhosis+ HCC | Total 26 patients with Cirrhosis+ hepatocellular carcinoma (HCC) (n= 26, age 61.61±9.85 years) are included in this study | |
| Cirrhosis+ Varices | Total 7 patients with Cirrhosis+ Varices (n= 7, age 48.42±15.80 years) are included in this study | |
| Cirrhosis+ Ascites | Total number of 26 patients with Cirrhosis+ Ascites (n= 26, age 55.96±8.51years) are included in this study | |
| Cirrhosis+ 2 Complications | Total number of 44 patients with cirrhosis with 2 complications (n=44, age 57.84±9.18 years) are included in this study | |
| Cirrhosis+ 3 Complications | Total number of 29 patients with cirrhosis and 3 or more complication (n=29, aged 59.64±12.61 years) are included in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications.
Gut microbial biomarkers, such as bacterial DNA and metabolic products in the feces, can provide valuable information about the gut microbiome in patients with decompensated cirrhosis, and may be useful in predicting the risk of complications and monitoring disease progression. However, more research is needed to fully understand the role of gut microbiota in decompensated cirrhosis and its complications, and to determine the utility of gut microbial biomarkers as a diagnostic or therapeutic tool in liver cirrhosis and cirrhosis with complications. Therefore, in this clinical trial the investigator will identify cirrhosis dependent bacterial species and metabolites which can have the ability to replace the invasive clinical biomarker for early detection of decompensation in cirrhosis.
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 posted28 Mar 2023
- Study start15 Aug 2018
- Primary completion15 Jun 2021
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Tae Suk, PhD, Principal investigator, Chuncheon Sacred Hallym hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786755
- Sponsor's protocol ID
- Liver cirrhosis, gut microbime
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05786755
- Acronym / sponsor ID
- Liver cirrhosis, gut microbime
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 28 Mar 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.
Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.
Detailed description
Stool samples were collected prospectively from 240 participants (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). 16S rRNA (ribosomal ribonucleic acid) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship,16S-based Microbiome Taxonomic Profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Total number of 52 Healthy Control Included in the study |
| Alcoholic Control | – | –Total number of 46 Alcoholic Control Included in the study |
| Only Cirrhosis | – | –Total 10 patients with only cirrhosis (n= 10, age 66.66±13.51 years) are included in this study |
| Cirrhosis+ HCC | – | –Total 26 patients with Cirrhosis+ hepatocellular carcinoma (HCC) (n= 26, age 61.61±9.85 years) are included in this study |
| Cirrhosis+ Varices | – | –Total 7 patients with Cirrhosis+ Varices (n= 7, age 48.42±15.80 years) are included in this study |
| Cirrhosis+ Ascites | – | –Total number of 26 patients with Cirrhosis+ Ascites (n= 26, age 55.96±8.51years) are included in this study |
| Cirrhosis+ 2 Complications | – | –Total number of 44 patients with cirrhosis with 2 complications (n=44, age 57.84±9.18 years) are included in this study |
| Cirrhosis+ 3 Complications | – | –Total number of 29 patients with cirrhosis and 3 or more complication (n=29, aged 59.64±12.61 years) are included in this study |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Microbiome Taxonomic Profiling was performed on 240 stool samples (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). All 142 patients were classified in six groups based on compilation: only cirrhosis, cirrhosis with hepatocellular carcinoma (HCC), cirrhosis with varices, cirrhosis with ascites, cirrhosis with 2 complications and cirrhosis with 3 or more complication.
Key inclusion criteria (12 listed)
- Registered in the Hallym University Hospital
- Presented initially sign of liver cirrhosis
- Patients must have the following laboratory parameters at screening:
- -
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications.
Time frame: 2 years
Gut microbial biomarkers, such as bacterial DNA and metabolic products in the feces, can provide valuable information about the gut microbiome in patients with decompensated cirrhosis, and may be useful in predicting the risk of complications and monitoring disease progression. However, more research is needed to fully understand the role of gut microbiota in decompensated cirrhosis and its complications, and to determine the utility of gut microbial biomarkers as a diagnostic or therapeutic tool in liver cirrhosis and cirrhosis with complications. Therefore, in this clinical trial the investigator will identify cirrhosis dependent bacterial species and metabolites which can have the ability to replace the invasive clinical biomarker for early detection of decompensation in cirrhosis.
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 28 Mar 2023.
- 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.
Ki Tae Suk, PhD principal investigator
Chuncheon Sacred Hallym hospital
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 Cirrhosis, 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 12 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 28 Mar 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?
Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications. (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 28 Mar 2023.