Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- eradication rate in the second-line treatment according to intention to treat (ITT) analysis
研究概览
简要总结
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.
详细描述
This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible
Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14)
D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days
D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
Group (B): bismuth quadruple therapy for 10 days (Q10)
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)
盲法说明
The technicians who performed the UBT test are blind to the treatment allocation
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.
排除标准
- •Patients will be excluded from the study if any one of the following criteria was present:
- •children and teenagers aged less than 20 years,
- •history of gastrectomy,
- •gastric malignancy, including adenocarcinoma and lymphoma,
- •previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
- •contraindication to treatment drugs,
- •pregnant or lactating women,
- •severe concurrent disease, or
- •Unwilling to accept random assignment of subjects.
研究组 & 干预措施
Sequential therapy for 14 days
Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
干预措施: Esomeprazole (S14) (Drug)
Sequential therapy for 14 days
Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
干预措施: Amoxicillin (ST14) (Drug)
Sequential therapy for 14 days
Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
干预措施: Clarithromycin (ST14) (Drug)
Sequential therapy for 14 days
Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
干预措施: Metronidazole (ST14) (Drug)
bismuth quadruple therapy for 10 days
Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
干预措施: Esomeprazole (BQ10) (Drug)
bismuth quadruple therapy for 10 days
Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
干预措施: dibismuth trioxide 120mg (BQ10) (Drug)
bismuth quadruple therapy for 10 days
Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
干预措施: Metronidazole (BQ10) (Drug)
bismuth quadruple therapy for 10 days
Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
干预措施: tetracycline (BQ10) (Drug)
结局指标
主要结局
eradication rate in the second-line treatment according to intention to treat (ITT) analysis
时间窗: 6 weeks
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.
次要结局
- Eradication rates in the second line treatment according to per protocol (PP) analysis(6 weeks)
- Changes of gut microbiota in the two treatment groups(2 weeks, 8 weeks, and 1 year)
- Re-infection rate one year after eradication therapy(1 year)
- Incidence of adverse effects in the first line therapy in the two treatment groups(2 weeks)