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Recruiting NCT07257562

Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

Observational Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PegIFNα2b+Nucleoside analog, PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • HBsAg clearance [Time frame: 48 months]

Eligibility criteria

Inclusion criteria

\- chronic hepatitis B patients

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT07257562 · MRCTA, ECFAH of FMU [2023]082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗