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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIFNα2b+Nucleoside analog | The patients receive both PegIFNα2b and Nucleoside analog therapy. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIFNα2b+Nucleoside analog | Drug | The patients receive both PegIFNα2b and Nucleoside analog therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
- chronic hepatitis B patients
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JinShui Pan | Contact | 0086+059187981658 | zdy20221021@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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.
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| 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. |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |