Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 and <80 years with a confirmed diagnosis of chronic hepatitis B by a clinician, who were in a low-level viremia state (as defined by predefined HBV DNA criteria), and required routine clinical evaluation, including virological markers, liver function tests, and liver-related assessments during standard care or follow-up; 2. Participants were required to provide written informed consent and to be able to comply with clinical examinations and fecal sample collection.
Exclusion criteria
Exclusion criteria: 1. Presence of other well-defined liver diseases, including but not limited to alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, genetic or metabolic liver diseases, and cirrhosis not related to hepatitis B; 2. Co-infection with other infectious diseases, including human immunodeficiency virus (HIV), syphilis, or tuberculosis; 3. History of psychiatric disorders or inability to adequately comply with study procedures; 4. Presence of malignancy or a history of malignancy within the past 5 years; 5. Any other conditions that, in the investigator’s judgment, would make the patient unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota characteristics (alpha/beta diversity, differentially abundant taxa, functional pathways);Hepatitis B virological markers (HBV DNA, HBsAg quantification, HBeAg status);Liver injury and fibrosis markers (ALT/AST, bilirubin, platelet count, FIB-4/APRI, liver stiffness measurement by elastography);Clinical outcomes including inflammation flare-up and fibrosis progression; | — |
Countries
China
Contacts
Xiangya Hospital, Central South University