Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE) (NCT07150195) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
China32 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Aged between 18 and 85 years, inclusive.
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.
What they're measuring
1
Microbiological and proteomic measurements
Timeframe: September 2025 - June 2026
Trial details
NCT IDNCT07150195
SponsorThe First Affiliated Hospital with Nanjing Medical University