Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

Condition(s) studied

Investigational drug(s) / intervention(s)

PegIFNα2b+Nucleoside analog: The patients receive both PegIFNα2b and Nucleoside analog therapy.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• HBsAg clearance — 48 months
  HBsAg clearance is confirmed when two consecutive measurements, taken at an interval of at least 2 weeks, demonstrate HBsAg levels below the assay's lower limit of detection (\< 0.05 IU/mL) as quantitatively determined by the Abbott Architect-i2000SR system with Chemiluminescent Microparticle Immunoassay (CMIA) technology.

Trial sites (1)

More First Affiliated Hospital of Fujian Medical University trials in China

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