Bacteroides fragilis plus branched-chain amino acids to help clear HBsAg
Official title: A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids on HBsAg Clearance
Run by First Affiliated Hospital of Fujian Medical University · NCT07257562 · Data updated 2026-11-12
This project tests whether adding Bacteroides fragilis and branched-chain amino acids to routine antiviral therapy helps people with chronic hepatitis B clear HBsAg.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07257562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic hepatitis B who are receiving PegIFNα2b plus a nucleoside analog and who do not have cancer, other liver diseases, or pregnancy are the intended participants.
✕Probably not a fit
Patients with malignancies, non-HBV liver diseases, or who are pregnant are excluded and would not be expected to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study following chronic hepatitis B patients who receive standard antiviral regimens based on PegIFNα2b and nucleoside analogs, with one group additionally taking Bacteroides fragilis and branched-chain amino acid (BCAA) supplements. Researchers will compare HBsAg/HBV clearance rates between the supplemented group and the control group receiving only the standard regimen. Key eligibility excludes patients with malignancies, other liver diseases, or pregnancy. The trial is conducted at the First Affiliated Hospital of Fujian Medical University in Fuzhou and does not involve randomized interventional assignment.
Why it matters
Potential benefit: If successful, the combined supplement could raise HBsAg clearance rates or shorten the time to viral loss for people with chronic hepatitis B on standard therapy.
How similar studies have gone: Microbiome modulation and nutritional supplements have shown preliminary promise in liver disease, but the specific combined use of Bacteroides fragilis and BCAAs for promoting HBsAg clearance is largely novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- chronic hepatitis B patients Exclusion Criteria: * patients with malignancies * patients with other liver diseases * pregnancy patients
Where it's running
-
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China Recruiting
Study contacts
- Study coordinator: JinShui Pan
- Email: zdy20221021@gmail.com
- Phone: 0086+059187981658
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.