Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication
研究概览
简要总结
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
- •Patient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures
排除标准
- •Recent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication
研究组 & 干预措施
Standard triple therapy
Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.
干预措施: Standard Triple Therapy (Drug)
Sequential Therapy
Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.
干预措施: Sequential Therapy (Drug)
结局指标
主要结局
Helicobacter pylori eradication
时间窗: 4 weeks after completion of treatment
次要结局
未报告次要终点
研究者
Byron Cryer
Staff Gastroenterologist
Dallas VA Medical Center