Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07257562

Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location status: Recruiting

Location contact

Anpeng Wu

CONTACT

[email protected]

0086+059187981029

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic hepatitis B patients

Exclusion criteria

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

Treatment and study plan

PegIFNα2b+Nucleoside analog

Drug

The patients receive both PegIFNα2b and Nucleoside analog therapy.

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

Drug

The patients received the concomitant administration of Bacteroides fragilis and BCAA, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog.

Primary outcomes

  1. HBsAg clearance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JinShui Pan

CONTACT

[email protected]

0086+059187981658

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.