Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance
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 →
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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