Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)

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.

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Key information

Conditions

Cirrhoses, Liver Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Encephalopathy Hepatic Encephalopathy (HE) Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Diagnosis of liver cirrhosis.
Elevated blood ammonia level.
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.
Neurological signs are normal or mild asterixis (flapping tremor) may be elicited.
Neuropsychological tests are abnormal.
Willing to participate and provides written informed consent.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Microbiological and proteomic measurements

Time frame: September 2025 - June 2026
- 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.
- 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.
- 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.

Secondary outcomes

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

Time frame: September 2025 - June 2026

I. Participant Characteristics Sex (n) Height (m) Weight (kg) Body Mass Index, BMI (kg/m²) Disease Duration (months) Description: Data collected via questionnaire, medical record review, and physical measurement. BMI was calculated from height and weight.

II. Cognitive Function Mini-Mental State Examination, MMSE Score (points, 0-30)

III. Laboratory Parameters - Hematology Hemoglobin (g/dL) White Blood Cell Count (×10⁹/L) Platelet Count (×10⁹/L)

IV. Laboratory Parameters - Coagulation Prothrombin Time (s)

V. Laboratory Parameters - Liver Function and Metabolism Blood Ammonia (μmol/L) Serum Albumin (g/dL) Alanine Aminotransferase, ALT (U/L) Aspartate Aminotransferase, AST (U/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Wenfang Cheng

CONTACT

[email protected]

(+86)13062589271

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 2, 2025
Registry last updated: Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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