Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Microbiological and proteomic measurements
概览
简要总结
The objective of this observational study is to compare the differences in proteomics and gut microbiome between the liver cirrhosis group without hepatic encephalopathy and the hepatic encephalopathy group through proteomics and microbiome analysis, screen out the characteristic proteomics and microbiome of patients with hepatic encephalopathy, guide clinical diagnosis and treatment, and conduct in-depth research on the pathogenesis of hepatic encephalopathy. The main questions it aims to answer are:
Are there any differences in serum proteomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main protein differences? There are differences in the fecal microbiome between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main microbial differences?
This study will screen for the differences in proteomes and gut microbiomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy, and identify the characteristic proteomes and microbiomes of patients with hepatic encephalopathy to guide clinical diagnosis and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the NHE (No Hepatic Encephalopathy) Group:
- •Aged between 18 and 85 years, inclusive.
- •Diagnosis of liver cirrhosis.
- •Normal blood ammonia level.
- •West-Haven Criteria grade 0 for Hepatic Encephalopathy.
- •Normal neurological signs.
- •Normal neuropsychological test results.
- •Willing to participate and provides written informed consent.
- •For the CHE (Covert Hepatic Encephalopathy) Group:
- •Aged between 18 and 85 years, inclusive.
排除标准
- •Diagnosis of any malignant tumor.
- •History of treatment for any malignant tumor.
- •Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.
- •Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.
- •Pregnancy, lactation, or puerperium.
结局指标
主要结局
Microbiological and proteomic measurements
时间窗: September 2025 - June 2026
1. Microbiome Alpha Diversity (Shannon Index) Variable Name: Shannon Index Unit of Measure: Unitless (Shannon Index is a dimensionless quantity) Description: Alpha diversity assessed from 16S rRNA sequencing data using the Shannon Index, analyzed via QIIME. 2. Relative Abundance of Specific Bacterial Taxa Variable Name: Relative Abundance Unit of Measure: % Description: The relative abundance of specific bacterial taxa, derived from 16S rRNA sequencing data analyzed using QIIME. 3. Proteomic Abundance of Specific Proteins Variable Name: Protein Abundance Unit of Measure: Arbitrary Intensity Units Description: Abundance of specific proteins measured by mass spectrometry-based proteomic analysis.
次要结局
- 1.Demographic and Clinical Characteristics Assessment using Data Collection Forms 2.Cognitive Function Assessment using Mini-Mental State Examination (MMSE) 3.Laboratory Blood Parameters Measured by Standard Clinical Laboratory Assays(September 2025 - June 2026)