A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.
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 —（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 scarred peptic ulcer disease
- •Ability and willingness to participate in the study and to sign and give informed consent
- •confirmed H. pylori infection
排除标准
- •Previous H. pylori eradication therapy
- •Less than 18 years old
- •With history of H. pylori infection treatment
- •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 regimen group
Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Esomeprazole (Drug)
Triple regimen group
Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Clarithromycin (Drug)
Triple regimen group
Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Metronidazole (Drug)
Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
干预措施: Esomeprazole (Drug)
Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
干预措施: Bismuth Potassium Citrate (Drug)
Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
干预措施: Clarithromycin (Drug)
Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
干预措施: Metronidazole (Drug)
High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Esomeprazole (Drug)
High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Bismuth Potassium Citrate (Drug)
High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Clarithromycin (Drug)
High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
干预措施: Metronidazole (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
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
Shanghai Jiao Tong University School of Medicine