Efficacy of High Dose of Amoxicillin And Metronidazole Plus Bismuth For Helicobacter Pylori Treatment In Naive Patients : A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Amoxicillin and metronidazole （400mg Q.D.S） based quadruple 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 amoxicillin and metronidazole (400mg thrice a day) based triple therapy and the addition of bismuth 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 80 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
Triple Therapy
Esomeprazole 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Esomeprazole (Drug)
Triple Therapy
Esomeprazole 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
干预措施: Amoxicillin, Metronidazole (Drug)
Bismuth Plus Triple 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)
Bismuth Plus Triple 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)
Bismuth Plus Triple 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)
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
- Rate of adverse effects(Within 7 days after completion of therapy)
- Compliance rate(Within 7 days after completion of therapy)
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Shanghai Jiao Tong University School of Medicine