ClinicalTrials.Veeva

Menu

Gut Mycobiome Profile in Alcoholic Liver Disease.

C

Chuncheon Sacred Heart Hospital

Status

Active, not recruiting

Conditions

Alcoholic Liver Disease

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

Healthy Control
Description:
Total number of 20 Healthy Control participants Included in the study
Alcoholic hepatitis
Description:
Total number of 30 Alcoholic hepatitis patients included in the study
Alcoholic cirrhosis
Description:
Total number of 30 alcoholic cirrhosis patients included in the study
Acute-on-Chronic Liver Failure
Description:
Total number of 15 alcoholic acute-on-chronic liver failure patients included in the study
Alcoholic Hepatocellular carcinoma
Description:
Total number of 25 Alcoholic Hepatocellular carcinoma patients included in the study

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems