Efficacy of Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with no previous treatment experience
排除标准
- •Less than 18 years old
- •With previous gastric surgery
- •Major systemic diseases
- •Pregnancy or lactation
- •Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
研究组 & 干预措施
Vonoprazan-containing Triple Therapy
Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Vonoprazan (Drug)
Vonoprazan-containing Triple Therapy
Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Amoxicillin, Metronidazole (Drug)
Empiric Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Amoxicillin, Metronidazole (Drug)
Empiric Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Bismuth Potassium Citrate (Drug)
Empiric Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Compliance rate(Within 7 days after completion of therapy)
- Rate of adverse effects(Within 7 days after completion of therapy)
研究者
Yingjie Ji
Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital
Shanghai East Hospital