Chronic Hepatitis BNCT07257562
Combined Use of Bacteroides Fragilis and BCAAs on HBsAg Clearance
An observational study of Chronic Hepatitis B, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PegIFNα2b+Nucleoside analog and PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- chronic hepatitis B patients
Who cannot join
- patients with malignancies
- patients with other liver diseases
- pregnancy patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Anpeng Wu, 0086+059187981029, fjydfyjg@163.com
About this study
Official title: A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- PegIFNα2b+Nucleoside analog, PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids
- Keywords
- Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegIFNα2b+Nucleoside analogDrug
The patients receive both PegIFNα2b and Nucleoside analog therapy.
PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino AcidsDrug
The patients received the concomitant administration of Bacteroides fragilis and BCAA, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog.
| Study group | Role | What they receive |
|---|---|---|
| PegIFNα2b+Nucleoside analog | The patients receive both PegIFNα2b and Nucleoside analog therapy. Receives: 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. Receives: Drug: PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257562
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU [2023]082
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 CHB patients receiving a standard antiviral regimen based on PegIFNα2b and nucleoside analog.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids on HBsAg Clearance
- ClinicalTrials.gov ID
- NCT07257562
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU [2023]082
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PegIFNα2b+Nucleoside analog | – | Drug: PegIFNα2b+Nucleoside analogThe patients receive both PegIFNα2b and Nucleoside analog therapy. |
| PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids | – | Drug: PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino AcidsThe patients received the concomitant administration of Bacteroides fragilis and Branched-Chain Amino Acids, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- chronic hepatitis B patients
Key exclusion criteria (3 listed)
- patients with malignancies
- patients with other liver diseases
- pregnancy patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegIFNα2b+Nucleoside analogThe patients receive both PegIFNα2b and Nucleoside analog therapy. | Drug | PegIFNα2b+Nucleoside analog |
| PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino AcidsThe patients received the concomitant administration of Bacteroides fragilis and BCAA, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog. | Drug | PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. 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 CHB patients receiving a standard antiviral regimen based on PegIFNα2b and nucleoside analog.
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JinShui Pan (0086+059187981658, zdy20221021@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg clearance (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.