NCT07257562

Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids on HBsAg Clearance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective observational study is to determine the effects of concomitant administration of Bacteroides fragilis and Branched-Chain Amino Acids on hepatitis B virus clearance. The primary question it aims to answer is whether this concomitant administration can promote HBV clearance. The study will observe the HBV clearance rate in chronic hepatitis B patients who receive Bacteroides fragilis and BCAA as a supplement to their routine antiviral therapy. For comparison, researchers will compare the clearance rate in this group to that observed in a control group of chronic hepatitis B patients receiving a standard antiviral regimen based on PegIFNα2b and nucleoside analogs.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	PegIFNα2b+Nucleoside analog	The patients receive both PegIFNα2b and Nucleoside analog therapy.
DRUG	PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids	The patients received the concomitant administration of Bacteroides fragilis and BCAA, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China