Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 主要终点
- Eradication
研究概览
简要总结
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.
详细描述
In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.
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
- None
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
- •Helicobacter pylori infection in biopsy
- •Eradication required
排除标准
- •Antibiotic received two weeks prior
- •Previous treatment for H pylori infection
- •Allergy to any of the treatment drugs
- •Smoking > 5 cigarettes daily.
研究组 & 干预措施
Sequential therapy
Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
干预措施: Sequential therapy (Drug)
Triple therapy
Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days
干预措施: Triple therapy (Drug)
结局指标
主要结局
Eradication
时间窗: 6 to 8 week after treatment
Helicobacter pylori in gastric biopsy
次要结局
- Side effects(two weeks after beginning of treatment)
研究者
Jorge Escobedo de la Pena
Head of the Clinical Research Centre
Coordinación de Investigación en Salud, Mexico