Efficacies of High-dose Dual Therapy With or Without Bismuth Versus Amoxicillin-metronidazole Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication - A Prospective, Randomized, Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 603
- 试验地点
- 1
- 主要终点
- to compare the eradication rate of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication.
研究概览
简要总结
Up to know, three is few large-scale, randomized study prospectively and simultaneously comparing the efficacy, adverse effects and patient compliance of high-dose dual therapy (HDDT) with or without bismuth versus amoxicillin-metronidazole bismuth quadruple therapy (AM-BQT) as first-line regimens for H. pylori eradication.
The aims of this study are:
- to compare the efficacy of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication;
- to compare the patient adherence and adverse effects of these treatment regimens;
- to investigate factors that may influence H. pylori eradication by these treatment regimens;
- to identify the effect of H. pylori eradication on the evolution of ecosystem of microbiota, and inflammatory parameters.
详细描述
This prospective multicenter randomized comparative study will be conducted at the National Taiwan University Hospital(NTUH), NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Buddhist Tzu Chi General Hospital, and Mennonite Christian Hospital in Hua-Lien City. Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease test, histology, and bacterial culture before treatment. If the patients did not receive anti-H. pylori therapy previously, these patients will be invited to enter this study for evaluating the efficacy of these 1st-line regimens.
A computed generated random numbers sequence will be blocked into three subgroups, say A, B, and C. After giving written informed consent, each patient will be randomly allocated, to one of three treatment groups:
group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);
group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days);
group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid , for 14 days);
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High-dose dual therapy
group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)
干预措施: High-dose dual therapy (rabeprazole, amoxicillin) (Drug)
Bismuth High-dose dual therapy
group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)
干预措施: Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate) (Drug)
Amoxicillin-Metronidazole Bismuth quadruple therapy
group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)
干预措施: Amoxicillin-Metronidazole Bismuth quadruple therapy (Drug)
结局指标
主要结局
to compare the eradication rate of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication.
时间窗: 5.5 years
The eradication rates (efficacy) of these regimens will be evaluated by the results of C13-urea breath test.
次要结局
- to compare the patient adherence and frequency of adverse effects of these treatment regimens.(5.5 years)