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Study on metabolome and microbiome changes in patients with hepatic encephalopathy

Study on metabolome and microbiome changes in patients with hepatic encephalopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074985
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic encephalopathy

Interventions

NHE:NA
CHE:NA
OHE:NA

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) NHE group inclusion criteria: Liver cirrhosis patients =18 years old with normal blood ammonia; West-Haven classification level 0, normal neurological signs, normal neuropsychological tests; The patient agrees to participate and signs the informed consent form. (2) CHE group inclusion criteria: Liver cirrhosis patients =18 years old with elevated blood ammonia; Subclinical hepatic encephalopathy and West-Haven classification Class 0, Class I HE, with no personality or behavioral changes or with mild clinical signs (such as mild cognitive impairment, attentional impairment, sleep disturbance, euphoria, or depression); Normal nervous system signs/flapping wing tremor can induce, abnormal neuropsychological tests; The patient agrees to participate and signs the informed consent form. (3) OHE inclusion criteria: Liver cirrhosis patients =18 years old with elevated blood ammonia; Mental abnormalities such as personality and behavior changes, coma and other neurological abnormalities, West-Haven classification 2~4 HE; Positive neurological signs such as ankle clonus; The patient's legal guardian agrees to participate and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) With malignant tumor; (2) With a history of malignant tumor treatment; (3) Complicated with serious heart, lung, brain, kidney disease or severe diabetic complications; (4) Antibiotics, prebiotics, probiotics and proton pump inhibitors have been used within three months; (5) Pregnancy or puerperium.

Design outcomes

Primary

MeasureTime frame
Proteomic data analysis(YNMT)· ;Microbiome nucleic acid analysis;

Countries

China

Contacts

Public ContactWenfang Cheng

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

chengwenfang@aliyun.com+86 130 6258 9271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026