Gut Mycobiome Profile in Alcoholic Liver Disease.

NCT ID: NCT05793190

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-11-30

Brief Summary

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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

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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

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Alcoholic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Control

Total number of 20 Healthy Control participants Included in the study

No interventions assigned to this group

Alcoholic hepatitis

Total number of 30 Alcoholic hepatitis patients included in the study

No interventions assigned to this group

Alcoholic cirrhosis

Total number of 30 alcoholic cirrhosis patients included in the study

No interventions assigned to this group

Acute-on-Chronic Liver Failure

Total number of 15 alcoholic acute-on-chronic liver failure patients included in the study

No interventions assigned to this group

Alcoholic Hepatocellular carcinoma

Total number of 25 Alcoholic Hepatocellular carcinoma patients included in the study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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:

1. onset of jaundice within 8 weeks,
2. ongoing consumption of ethanol of \>40 for women or \>60 in men for 6 months or \<60 days of abstinence before onset of jaundice,
3. Aspartate transaminase (AST\>50), AST:ALT\>1.5 and both \<400 IU/L,
4. Total bilirubin \>3, or liver biopsy showing histologic features of ALD.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki Tae Suk, PhD

Role: PRINCIPAL_INVESTIGATOR

Chuncheon Sacred Hallym hospital

Locations

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Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 34896404 (View on PubMed)

Hindson 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.

Reference Type BACKGROUND
PMID: 35017674 (View on PubMed)

Mbaye 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.

Reference Type BACKGROUND
PMID: 36359786 (View on PubMed)

Lang 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.

Reference Type BACKGROUND
PMID: 31228214 (View on PubMed)

Zeng 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.

Reference Type BACKGROUND
PMID: 34995410 (View on PubMed)

Other Identifiers

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GMALD

Identifier Type: -

Identifier Source: org_study_id