Alcoholic Liver DiseaseNCT05793190
Gut Mycobiome Profile in Alcoholic Liver Disease.
An observational study of Alcoholic Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The fecal mycobiome, which refers to the community of fungi that resides in the human gut, is an important component of the gut microbiome. Research has shown that changes in the gut microbiome, including alterations in the fecal mycobiome, may play a role in the development and progression of alcoholic liver disease… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcoholic Liver Disease
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2021to 30 Nov 2023
- How long will I take part?
- 1 Year
- 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: Total number of 500 participants were enrolled in this clinical trial, out those 500 participants only 120 were met with the inclusion criteria therefore 380 participants were excluded from this clicial trial. Fecal samples were collected prospectively from 120 participants including Healthy Control (HC=20), Alcoholic hepatitis (AH=30), alcoholic cirrhosis (AC=30), Acute-on-Chronic Liver Failure (ACLF=15), Alcoholic cirrhosis (AC=25).
Who may be able to join
- Adult patients admitted to Chuncheon Sacred Hallym hospital with a diagnosis of ALD will be screened and potentially recruited.
- ALD patients will be identified based on the recent American Association of the Study of Liver Disease (AASLD) guidelines:
- onset of jaundice within 8 weeks,
- ongoing consumption of ethanol of >40 for women or >60 in men for 6 months or <60 days of abstinence before onset of jaundice,
- Aspartate transaminase (AST>50), AST:ALT>1.5 and both <400 IU/L,
- Total bilirubin >3, or liver biopsy showing histologic features of ALD.
Who cannot join
- If patients have a history of inflammatory bowel disease, irritable bowel syndrome, gastrointestinal malignancy, or gastrointestinal surgery.
- Patients with acute pancreatitis or history of chronic pancreatitis will also be excluded. The diagnosis of acute pancreatitis and chronic pancreatitis will be ascertained from their history and physical.
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
Official title: Feal Mycobiome Profiling Depending on Alcoholic Liver Disease Severity.
The fecal mycobiome, which refers to the community of fungi that resides in the human gut, is an important component of the gut microbiome. Research has shown that changes in the gut microbiome, including alterations in the fecal mycobiome, may play a role in the development and progression of alcoholic liver disease (ALD).One study published in the journal Gut Microbes found that individuals with ALD had a different gut microbiome composition compared to healthy individuals, including alterations in the levels of certain fungal species. Specifically, the study found that there was an increase in the abundance of the fungal genus Saccharomyces in individuals with ALD. This is significant because Saccharomyces is known to produce ethanol, which can contribute to liver damage in individuals with ALD.Another study published in the journal PLOS One found that there were differences in the levels of fungal metabolites in the fecal samples of individuals with ALD compared to healthy individuals. Specifically, the study found that there were higher levels of certain fungal metabolites, including acetaldehyde and ethanol, in the fecal samples of individuals with ALD.These findings suggest that the fecal mycobiome may play an important role in the development and progression of ALD. Maintaining a healthy gut microbiome through a balanced diet and other lifestyle factors may be an important strategy for preventing and managing ALD, and further research into the role of the fecal mycobiome in this condition is warranted.
Read the detailed description
Fecal samples were collected prospectively from 120 participants including Healthy Control (HC=20), Alcoholic hepatitis (AH=30), alcoholic cirrhosis (AC=30), Acute-on-Chronic Liver Failure (ACLF=15), Alcoholic Hepatocellular carcinoma (AHCC=25). Mycobial DNA were isolated from collected fecal samples by using DNeasy powersoil pro kit and subjected for nuclear ribosomal RNA internal transcribed spacer (ITS) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship, ITS-based Mycobiome Taxonomic Profiling was performed to discovery gut mycobial compositional shift along with ALD severity progression. To discover compositional shift along with ALD severity progression, various statistical analysis method is going to be performed which includes standard mean based differential analysis such ANOVA, Principle component analysis to established the basic compositional variation in all the groups.
- Conditions
- Alcoholic Liver Disease
- Medical subject headings
- Liver Diseases, Alcoholic
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 20 Healthy Control participants Included in the study | |
| Alcoholic hepatitis | Total number of 30 Alcoholic hepatitis patients included in the study | |
| Alcoholic cirrhosis | Total number of 30 alcoholic cirrhosis patients included in the study | |
| Acute-on-Chronic Liver Failure | Total number of 15 alcoholic acute-on-chronic liver failure patients included in the study | |
| Alcoholic Hepatocellular carcinoma | Total number of 25 Alcoholic Hepatocellular carcinoma patients included in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut mycobiome compositional signature in Alcoholic liver diseases
Research has shown that the gut mycobiome, which refers to the community of fungi that resides in the human gut, may have a distinct compositional signature in individuals with alcoholic liver disease (ALD). Microorganisms found that individuals with ALD had a higher abundance of certain fungal species, including Candida, Malassezia, and Saccharomyces, compared to healthy individuals and genus Saccharomyces. Saccharomyces is of particular interest in ALD as it is known to produce ethanol, which can contribute to liver damage in individuals with ALD. Furthermore, higher levels of certain fungal metabolites, including acetaldehyde and ethanol, in the fecal samples of individuals with ALD. These findings suggest that the gut mycobiome may play a role in the development and progression of ALD, and that alterations in the composition of the gut mycobiome may be a potential biomarker for this condition.
Measured: 2 years
Gut mycobiome biomarkers identification for early detection of decompensated alcoholic liver disease
While there is still much research to be done, studies have identified potential gut mycobiome biomarkers that may be used for the early detection of ALD and its progression to more severe stages. Overall, previous findings suggest that the gut mycobiome may be a valuable source of biomarkers for the early detection of ALD. However, further research is needed to confirm the accuracy and reliability of these potential biomarkers and to determine the best approach for their clinical use.
Measured: 2 years
Health beneficial Gut Mycobiome identification in alcoholic liver disease
While research has primarily focused on the detrimental effects of altered gut mycobiome composition in individuals with alcoholic liver disease (ALD), there is also evidence to suggest that certain fungal species may have health benefits and could potentially play a role in the prevention or treatment of ALD. The fungal genus Debaryomyces was present at higher levels in the fecal samples of healthy individuals compared to individuals with ALD. Fungal species Rhodotorula mucilaginosa was able to reduce liver damage in rats with ALD. Rhodotorula mucilaginosa and Debaryomyces has also been shown to have anti-inflammatory and antioxidant properties, which may contribute to its protective effects on the liver. These findings suggest that certain fungal species may have health benefits and could potentially be used in the prevention or treatment of ALD.
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 posted31 Mar 2023
- Study start15 Apr 2021
- Primary completion25 Jan 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Liver DiseaseStudies 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
- 500 participants (estimated)
- Target duration
- 1 Year
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
- NCT05793190
- Sponsor's protocol ID
- GMALD
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demir M, Lang S, Hartmann P, Duan Y, Martin A, Miyamoto Y, Bondareva M, Zhang X, Wang Y, Kasper P, Bang C, Roderburg C, Tacke F, Steffen HM, Goeser T, Kruglov A, Eckmann L, Starkel P, Fouts DE, Schnabl B. The fecal mycobiome in non-alcoholic fatty liver disease. J Hepatol. 2022 Apr;76(4):788-799. doi: 10.1016/j.jhep.2021.11.029. Epub 2021 Dec 10.
PubMed 34896404Hindson J. Distinct faecal mycobiome in patients with NAFLD. Nat Rev Gastroenterol Hepatol. 2022 Feb;19(2):79. doi: 10.1038/s41575-022-00576-z. No abstract available.
PubMed 35017674Mbaye B, Borentain P, Magdy Wasfy R, Alou MT, Armstrong N, Mottola G, Meddeb L, Ranque S, Gerolami R, Million M, Raoult D. Endogenous Ethanol and Triglyceride Production by Gut Pichia kudriavzevii, Candida albicans and Candida glabrata Yeasts in Non-Alcoholic Steatohepatitis. Cells. 2022 Oct 27;11(21):3390. doi: 10.3390/cells11213390.
PubMed 36359786Lang S, Duan Y, Liu J, Torralba MG, Kuelbs C, Ventura-Cots M, Abraldes JG, Bosques-Padilla F, Verna EC, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross D, Lucey MR, Louvet A, Mathurin P, Garcia-Tsao G, Ho SB, Tu XM, Bataller R, Starkel P, Fouts DE, Schnabl B. Intestinal Fungal Dysbiosis and Systemic Immune Response to Fungi in Patients With Alcoholic Hepatitis. Hepatology. 2020 Feb;71(2):522-538. doi: 10.1002/hep.30832. Epub 2019 Aug 20.
PubMed 31228214Zeng S, Schnabl B. Roles for the mycobiome in liver disease. Liver Int. 2022 Apr;42(4):729-741. doi: 10.1111/liv.15160. Epub 2022 Jan 17.
PubMed 34995410
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feal Mycobiome Profiling Depending on Alcoholic Liver Disease Severity.
- ClinicalTrials.gov ID
- NCT05793190
- Acronym / sponsor ID
- GMALD
- Conditions
- Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 31 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.
The fecal mycobiome, which refers to the community of fungi that resides in the human gut, is an important component of the gut microbiome. Research has shown that changes in the gut microbiome, including alterations in the fecal mycobiome, may play a role in the development and progression of alcoholic liver disease (ALD).One study published in the journal Gut Microbes found that individuals with ALD had a different gut microbiome composition compared to healthy individuals, including alterations in the levels of certain fungal species. Specifically, the study found that there was an increase in the abundance of the fungal genus Saccharomyces in individuals with ALD. This is significant because Saccharomyces is known to produce ethanol, which can contribute to liver damage in individuals with ALD.Another study published in the journal PLOS One found that there were differences in the levels of fungal metabolites in the fecal samples of individuals with ALD compared to healthy individuals. Specifically, the study found that there were higher levels of certain fungal metabolites, including acetaldehyde and ethanol, in the fecal samples of individuals with ALD.These findings suggest that the fecal mycobiome may play an important role in the development and progression of ALD. Maintaining a healthy gut microbiome through a balanced diet and other lifestyle factors may be an important strategy for preventing and managing ALD, and further research into the role of the fecal mycobiome in this condition is warranted.
Detailed description
Fecal samples were collected prospectively from 120 participants including Healthy Control (HC=20), Alcoholic hepatitis (AH=30), alcoholic cirrhosis (AC=30), Acute-on-Chronic Liver Failure (ACLF=15), Alcoholic Hepatocellular carcinoma (AHCC=25). Mycobial DNA were isolated from collected fecal samples by using DNeasy powersoil pro kit and subjected for nuclear ribosomal RNA internal transcribed spacer (ITS) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship, ITS-based Mycobiome Taxonomic Profiling was performed to discovery gut mycobial compositional shift along with ALD severity progression. To discover compositional shift along with ALD severity progression, various statistical analysis method is going to be performed which includes standard mean based differential analysis such ANOVA, Principle component analysis to established the basic compositional variation in all the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Total number of 20 Healthy Control participants Included in the study |
| Alcoholic hepatitis | – | –Total number of 30 Alcoholic hepatitis patients included in the study |
| Alcoholic cirrhosis | – | –Total number of 30 alcoholic cirrhosis patients included in the study |
| Acute-on-Chronic Liver Failure | – | –Total number of 15 alcoholic acute-on-chronic liver failure patients included in the study |
| Alcoholic Hepatocellular carcinoma | – | –Total number of 25 Alcoholic Hepatocellular carcinoma patients included in the study |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Total number of 500 participants were enrolled in this clinical trial, out those 500 participants only 120 were met with the inclusion criteria therefore 380 participants were excluded from this clicial trial. Fecal samples were collected prospectively from 120 participants including Healthy Control (HC=20), Alcoholic hepatitis (AH=30), alcoholic cirrhosis (AC=30), Acute-on-Chronic Liver Failure (ACLF=15), Alcoholic cirrhosis (AC=25).
Key inclusion criteria (6 listed)
- Adult patients admitted to Chuncheon Sacred Hallym hospital with a diagnosis of ALD will be screened and potentially recruited.
- ALD patients will be identified based on the recent American Association of the Study of Liver Disease (AASLD) guidelines:
Key exclusion criteria (2 listed)
- If patients have a history of inflammatory bowel disease, irritable bowel syndrome, gastrointestinal malignancy, or gastrointestinal surgery.
- Patients with acute pancreatitis or history of chronic pancreatitis will also be excluded. The diagnosis of acute pancreatitis and chronic pancreatitis will be ascertained from their history and physical.
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 mycobiome compositional signature in Alcoholic liver diseases
Time frame: 2 years
Research has shown that the gut mycobiome, which refers to the community of fungi that resides in the human gut, may have a distinct compositional signature in individuals with alcoholic liver disease (ALD). Microorganisms found that individuals with ALD had a higher abundance of certain fungal species, including Candida, Malassezia, and Saccharomyces, compared to healthy individuals and genus Saccharomyces. Saccharomyces is of particular interest in ALD as it is known to produce ethanol, which can contribute to liver damage in individuals with ALD. Furthermore, higher levels of certain fungal metabolites, including acetaldehyde and ethanol, in the fecal samples of individuals with ALD. These findings suggest that the gut mycobiome may play a role in the development and progression of ALD, and that alterations in the composition of the gut mycobiome may be a potential biomarker for this condition.
Gut mycobiome biomarkers identification for early detection of decompensated alcoholic liver disease
Time frame: 2 years
While there is still much research to be done, studies have identified potential gut mycobiome biomarkers that may be used for the early detection of ALD and its progression to more severe stages. Overall, previous findings suggest that the gut mycobiome may be a valuable source of biomarkers for the early detection of ALD. However, further research is needed to confirm the accuracy and reliability of these potential biomarkers and to determine the best approach for their clinical use.
Health beneficial Gut Mycobiome identification in alcoholic liver disease
Time frame: 2 years
While research has primarily focused on the detrimental effects of altered gut mycobiome composition in individuals with alcoholic liver disease (ALD), there is also evidence to suggest that certain fungal species may have health benefits and could potentially play a role in the prevention or treatment of ALD. The fungal genus Debaryomyces was present at higher levels in the fecal samples of healthy individuals compared to individuals with ALD. Fungal species Rhodotorula mucilaginosa was able to reduce liver damage in rats with ALD. Rhodotorula mucilaginosa and Debaryomyces has also been shown to have anti-inflammatory and antioxidant properties, which may contribute to its protective effects on the liver. These findings suggest that certain fungal species may have health benefits and could potentially be used in the prevention or treatment of ALD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 34896404Demir M, Lang S, Hartmann P, Duan Y, Martin A, Miyamoto Y, Bondareva M, Zhang X, Wang Y, Kasper P, Bang C, Roderburg C, Tacke F, Steffen HM, Goeser T, Kruglov A, Eckmann L, Starkel P, Fouts DE, Schnabl B. The fecal mycobiome in non-alcoholic fatty liver disease. J Hepatol. 2022 Apr;76(4):788-799. doi: 10.1016/j.jhep.2021.11.029. Epub 2021 Dec 10.
- Background: PubMed 35017674Hindson J. Distinct faecal mycobiome in patients with NAFLD. Nat Rev Gastroenterol Hepatol. 2022 Feb;19(2):79. doi: 10.1038/s41575-022-00576-z. No abstract available.
- Background: PubMed 36359786Mbaye B, Borentain P, Magdy Wasfy R, Alou MT, Armstrong N, Mottola G, Meddeb L, Ranque S, Gerolami R, Million M, Raoult D. Endogenous Ethanol and Triglyceride Production by Gut Pichia kudriavzevii, Candida albicans and Candida glabrata Yeasts in Non-Alcoholic Steatohepatitis. Cells. 2022 Oct 27;11(21):3390. doi: 10.3390/cells11213390.
- Background: PubMed 31228214Lang S, Duan Y, Liu J, Torralba MG, Kuelbs C, Ventura-Cots M, Abraldes JG, Bosques-Padilla F, Verna EC, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross D, Lucey MR, Louvet A, Mathurin P, Garcia-Tsao G, Ho SB, Tu XM, Bataller R, Starkel P, Fouts DE, Schnabl B. Intestinal Fungal Dysbiosis and Systemic Immune Response to Fungi in Patients With Alcoholic Hepatitis. Hepatology. 2020 Feb;71(2):522-538. doi: 10.1002/hep.30832. Epub 2019 Aug 20.
- Background: PubMed 34995410Zeng S, Schnabl B. Roles for the mycobiome in liver disease. Liver Int. 2022 Apr;42(4):729-741. doi: 10.1111/liv.15160. Epub 2022 Jan 17.
- 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 Alcoholic Liver Disease, 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 6 inclusion and 2 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 31 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?
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?
Gut mycobiome compositional signature in Alcoholic liver diseases (time frame: 2 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 NCT05793190, which also lists 5 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 31 Mar 2023.