The First Affiliated Hospital with Nanjing Medical University
Phase
Observational
Started
2025-09
Last updated
2025-09-25
Condition(s) studied
Cirrhoses, LiverHepatic Encephalopathy (HE)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
For the NHE (No Hepatic Encephalopathy) Group:
1. Aged between 18 and 85 years, inclusive.
2. Diagnosis of liver cirrhosis.
3. Normal blood ammonia level.
4. West-Haven Criteria grade 0 for Hepatic Encephalopathy.
5. Normal neurological signs.
6. Normal neuropsychological test results.
7. Willing to participate and provides written informed consent.
For the CHE (Covert Hepatic Encephalopathy) Group:
1. Aged between 18 and 85 years, inclusive.
2. Diagnosis of liver cirrhosis.
3. Elevated blood ammonia level.
4. Diagnosis of Covert Hepatic Encephalopathy (West-Haven Criteria grade 0 or I).
* Grade 0: No personality or behavioral changes but abnormal neuropsychological tests.
* Grade I: Mild cognitive impairment, lack of awareness, euphoria or anxiety, shortened attention span, or impaired performance of addition/subtraction.
5. Neurological signs are normal or mild asterixis (flapping tremor) may be elicited.
6. Neuropsychological tests are abnormal.
7. Willing to participate and provides written informed consent.
Exclusion Criteria:
1. Diagnosis of any malignant tumor.
2. History of treatment for any malignant tumor.
3. Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.
4. Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.
5. Pregnancy, lactation, or puerperium.
Primary outcome measure(s)
Microbiological and proteomic measurements — 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.
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.