Hepatic Dysfunction
Conditions
Interventions
Mild hepatic impairment:NA
Moderate hepatic impairment:NA
Severe hepatic impairment:NA
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-75 years, male or female 2) Body mass index (BMI) ranging from 18.0 to 32.0 kg/m^2 3) For subjects with hepatic dysfunction, the following criteria must be met: Hepatic dysfunction caused by pre-existing primary liver diseases, confirmed as stable (>1 month) through medical history, physical examination, laboratory tests, or imaging studies; No medication use within 4 weeks prior to screening, or for those requiring long-term treatment for hepatic dysfunction and/or other comorbidities, medication regimens should remain stable for at least 4 weeks.
Exclusion criteria
Exclusion criteria: 1) Severe infections, trauma, gastrointestinal surgery, or other major surgical procedures within 5 weeks prior to screening. 2) Use of antibiotics for 3 consecutive days or longer within the past 4 weeks. 3) Alcohol abuse. 4) Patients with any of the following conditions: Acute or chronic renal insufficiency, uremia; congenital heart disease; systemic lupus; erythematosus; Hematologic disorders (aplastic anemia, idiopathic thrombocytopenic purpura, or anemia with hemoglobin <10 g/dL); epilepsy; severe psychiatric disorders within the last 6 months; severe organic diseases (e.g., malignant tumors/cancer, coronary artery disease, myocardial infarction, stroke); infectious diseases (e.g., tuberculosis, AIDS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal metagenomics;Fecal Metagenomics;Fecal bile acids;Serum bile acids;Chile-Pugh score; | — |
Secondary
| Measure | Time frame |
|---|---|
| General Information (included personal conditions, underlying diseases, and underlying medications); | — |
Countries
China
Contacts
Public ContactLiu Rui
The First Affiliated Hospital of Soochow University
Outcome results
None listed