Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- The eradication rates as a measure of the efficacy of HDDT, and BQT
研究概览
简要总结
Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication.
The aims of this study are:
- to compare the efficacy of HDDT, and BQT as rescue regimen in 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.
详细描述
Participants, 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 teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.
If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:
group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);
group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);
All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.
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-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days)
干预措施: High-dose dual therapy (rabeprazole, amoxicillin) (Drug)
Bismuth-containing quadruple therapy
group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days)
干预措施: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) (Drug)
结局指标
主要结局
The eradication rates as a measure of the efficacy of HDDT, and BQT
时间窗: 3.5 years
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
次要结局
- Amount of unused medication post treatment as a measure of patient adherence.(3.5 years)
- Number of participants with adverse effects as a measure of safety(3.5 years)