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

NCT07150195 | Not Yet Recruiting

• 1 other identifier: Wenfang Chen
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhoses, Liver; Hepatic Encephalopathy (HE)

Outcome Measures

Primary Outcomes (1)

• Microbiological and proteomic measurements

  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.

  September 2025 - June 2026

Secondary Outcomes (1)

• 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

Study Arms (2)

Liver cirrhosis non-hepatic encephalopathy group (NHE group)

Patients with liver cirrhosis aged ≥18 years, with normal blood ammonia; West-Haven classification 0, normal neurological signs, and normal neuropsychological tests; The patient agreed to participate and signed the informed consent form.

Liver cirrhosis hepatic encephalopathy group (HE group）

Patients with liver cirrhosis aged 18 years or older, with elevated blood ammonia; Subclinical hepatic encephalopathy and West-Haven classification of grades 0, 1 to 4 HE, presenting with mental abnormalities such as personality and behavioral changes, and neurological abnormalities such as coma; Neurological signs are normal/flapping tremors can be elicited/positive neurological signs such as ankle clonus, and neuropsychological tests are abnormal; The patient/legal guardian agrees to participate and signs the informed consent form.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population: A hospital-based cohort of adult patients (aged 18-85 years) with a confirmed diagnosis of liver cirrhosis, specifically recruited to form two distinct study groups based on the presence or absence of hepatic encephalopathy (HE) and blood ammonia levels. Sampling Method: Non-Probability Sample. Participants will be consecutively recruited from inpatient units. A purposive sampling strategy will be employed to ensure the successful enrollment of a sufficient number of participants in the Hepatic Encephalopathy (HE) group.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Related Publications (5)

• Munk Lauridsen M, Jonasson E, Bajaj JS. Microbial Approaches to Treat and Prevent Hepatic Encephalopathy. Gastroenterol Clin North Am. 2025 Jun;54(2):429-451. doi: 10.1016/j.gtc.2024.12.006. Epub 2025 Jan 23.

  PMID: 40348497 RESULT

• Engelmann C. Rethinking hepatic encephalopathy: Gut microbes, neurotoxins and the therapeutic horizon. J Hepatol. 2025 Aug;83(2):601-603. doi: 10.1016/j.jhep.2025.04.036. Epub 2025 May 27. No abstract available.

  PMID: 40436647 RESULT

• Li S, Xu Z, Diao H, Zhou A, Tu D, Wang S, Feng Y, Feng X, Lai Y, Yang S, Tang B. Gut microbiome alterations and hepatic encephalopathy post-TIPS in liver cirrhosis patients. J Transl Med. 2025 Jul 4;23(1):745. doi: 10.1186/s12967-025-06774-y.

  PMID: 40615853 RESULT

• Mancini A, Campagna F, Amodio P, Tuohy KM. Gut : liver : brain axis: the microbial challenge in the hepatic encephalopathy. Food Funct. 2018 Mar 1;9(3):1373-1388. doi: 10.1039/c7fo01528c. Epub 2018 Feb 27.

  PMID: 29485654 RESULT

• Stengel S, Stallmach A, Richter K, Landrock A, Hampe J, Bruns T. Serum metabolic signatures in patients with overt hepatic encephalopathy. J Hepatol. 2017 Nov;67(5):1114-1115. doi: 10.1016/j.jhep.2017.06.030. Epub 2017 Jul 6. No abstract available.

  PMID: 28690175 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Fecal sample: Use a fecal collection tube to collect half of the tube. Collect the middle section of the fecal sample to avoid urine contamination. Mark the tube with the number, name, date and fecal score on the outside. Hand it over to the staff and immediately fresh divide it into 4 tubes, each tube about 500mg. Store it in a refrigerator at -80℃ and avoid freezing and thawing. 2\. Serum sample: Use a red-capped sterile blood collection tube (without additives) to draw 3ml of blood, and centrifuge to take 1.5ml of the supernatant. Evenly aliquot into 3 tubes for labeling, each tube approximately 500 μ l, and store in a -80 ° C refrigerator.

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Wenfang Cheng

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

  STUDY DIRECTOR

Central Study Contacts

Wenfang Cheng

CONTACT

(+86)13062589271; chengwenfang@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-08

Locations

CN (1)