A Unique Quadruple Regimen for of Helicobacter Pylori
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of patients with eradicated Helicobacter infection
研究概览
简要总结
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.
However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective
详细描述
Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent
排除标准
- •Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.
研究组 & 干预措施
Quadruple therapy
Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
干预措施: Quadruple therapy (Drug)
Classic treatment
Omeprazole, clarithromycin, amoxicillin
干预措施: Classic treatment (Drug)
结局指标
主要结局
Number of patients with eradicated Helicobacter infection
时间窗: 6 months
Number of patients with eradicated infection
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Investigator
Tanta University