Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Chronic Hepatitis B

Treatments: Drug: PegIFNα2b+Nucleoside analog; Drug: PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids

Study type: Observational

Funder types: Other

Identifiers

NCT07257562

MRCTA, ECFAH of FMU [2023]082

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- chronic hepatitis B patients

Exclusion criteria

• patients with malignancies
• patients with other liver diseases
• pregnancy patients

Trial design

40 participants in 2 patient groups

PegIFNα2b+Nucleoside analog

Description:

The patients receive both PegIFNα2b and Nucleoside analog therapy.

Treatment:

Drug: PegIFNα2b+Nucleoside analog

PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids

Description:

The patients received the concomitant administration of Bacteroides fragilis and Branched-Chain Amino Acids, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog.

Treatment:

Drug: PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids