Bacteroides fragilis plus branched-chain amino acids to help clear HBsAg
A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids on HBsAg Clearance
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07257562 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- chronic hepatitis B patients Exclusion Criteria: * patients with malignancies * patients with other liver diseases * pregnancy patients
Where this trial is running
Fuzhou, Fujian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.