Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance

NCT07257562 | Recruiting

• 1 other identifier: MRCTA, ECFAH of FMU [2023]082
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBsAg clearance

  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.

  48 months

Study Arms (2)

PegIFNα2b+Nucleoside analog

The patients receive both PegIFNα2b and Nucleoside analog therapy.

Drug: PegIFNα2b+Nucleoside analog

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

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.

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

Interventions

PegIFNα2b+Nucleoside analog DRUG

The patients receive both PegIFNα2b and Nucleoside analog therapy.

PegIFNα2b+Nucleoside analog

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is patients with chronic hepatitis B who are receiving both PegIFNα2b and nucleoside analog therapy with or without concomitant administration of Bacteroides fragilis and Branched-Chain Amino Acids.

You may qualify if:

• \- chronic hepatitis B patients

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

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

Central Study Contacts

JinShui Pan

CONTACT

0086+059187981658; zdy20221021@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)