A Prospective Observational Study on the Effects of Concomitant Administration of Bacteroides Fragilis and Branched-Chain Amino Acids on HBsAg Clearance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HBsAg clearance
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- chronic hepatitis B patients
排除标准
- •patients with malignancies
- •patients with other liver diseases
- •pregnancy patients
研究组 & 干预措施
PegIFNα2b+Nucleoside analog
The patients receive both PegIFNα2b and Nucleoside analog therapy.
干预措施: PegIFNα2b+Nucleoside analog (Drug)
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.
干预措施: PegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids (Drug)
结局指标
主要结局
HBsAg clearance
时间窗: 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.
次要结局
未报告次要终点