Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhoses, Liver, Hepatic Encephalopathy (HE). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Microbiological and proteomic measurements [Time frame: September 2025 - June 2026]
Secondary outcome measures (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 [Time frame: September 2025 - June 2026]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical Univers — Nanjing
Publications
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07150195 · Wenfang Chen