UnknownNot Applicable

Gut Mycobiome Profile in Alcoholic Liver Disease.

South Korea500 participantsStarted 2021-04-15

Plain-language 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 (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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gut mycobiome compositional signature in Alcoholic liver diseases

Timeframe: 2 years

Gut mycobiome biomarkers identification for early detection of decompensated alcoholic liver disease

Timeframe: 2 years

Health beneficial Gut Mycobiome identification in alcoholic liver disease

Timeframe: 2 years

Trial details

NCT IDNCT05793190

SponsorChuncheon Sacred Heart Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-25

View on ClinicalTrials.gov More Alcoholic Liver Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.