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

Nanjing Medical University

Status: Not yet enrolling

Conditions: Hepatic Encephalopathy (HE); Cirrhoses, Liver

Study type: Observational

Funder types: Other

Identifiers

NCT07150195

Wenfang Chen

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

Liver cirrhosis non-hepatic encephalopathy group (NHE group)

Description:

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）

Description:

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.