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

NCT07150195 — Not yet recruiting, 32 participants, The First Affiliated Hospital with Nanjing Medical University
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RegistryNCT07150195
StatusNot yet recruiting
Study typeObservational
Enrollment32 (Estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University (Other)
ConditionsCirrhoses, Liver, Hepatic Encephalopathy (HE)
Datesstart 2025-09-01 (estimated), primary completion 2025-09-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-09-02, last updated 2025-09-25
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Cirrhoses, Liver All trials for Hepatic Encephalopathy (HE)

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
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.

+Outcome measures

Primary outcomes

  • 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.

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 [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)

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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.

+Locations (1)

FacilityCityCountryStatus
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical UniversityNanjing, JiangsuChina

+Publications

  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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

+Study documents

+Investigators

  • Wenfang Cheng, Study director, Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University