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A Study of Gut Bacteria in Patients with Chronic Hepatitis B with Low Levels of Virus

A Study of Gut Bacteria in Patients with Chronic Hepatitis B with Low Levels of Virus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123800
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Hepatitis B

Interventions

Low-level viremia (LLV) group:None
Complete virological response (CVR) group:None

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

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

MeasureTime 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

Public ContactPei Siya

Xiangya Hospital, Central South University

siyapei95@163.com+86 187 7489 3560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026