Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
NCT ID: NCT07150195
Last Updated: 2025-09-25
Study Results
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Basic Information
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NOT_YET_RECRUITING
32 participants
OBSERVATIONAL
2025-09-30
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Wenfang Cheng
Role: STUDY_DIRECTOR
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
Locations
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Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Wenfang Chen
Identifier Type: -
Identifier Source: org_study_id
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