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临床试验/NCT05793190
NCT05793190进行中(未招募)不适用

Feal Mycobiome Profiling Depending on Alcoholic Liver Disease Severity.

Chuncheon Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
试验地点
1
主要终点
Gut mycobiome compositional signature in Alcoholic liver diseases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Gut mycobiome compositional signature in Alcoholic liver diseases

时间窗: 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.

Health beneficial Gut Mycobiome identification in alcoholic liver disease

时间窗: 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.

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Chuncheon Sacred Heart Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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