Status:
NOT_YET_RECRUITING
Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Cirrhoses, Liver
Hepatic Encephalopathy (HE)
Eligibility:
All Genders
18-85 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07150195
Start Date
September 1 2025
End Date
December 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China