Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 339
- 主要终点
- Eradication rate
研究概览
简要总结
Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.
详细描述
A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H.pylori-positive outpatients with endoscopically proven chronic gastritis
- •H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
- •Treatment-naive patients for eradication of H.pylori infection
- •Fully informed and agreed to participate in this study
排除标准
- •Age <18 years or >70 years
- •Allergy to any of the study drugs
- •Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
- •Previous gastric or esophageal surgery
- •Patients with malignancy or severe comorbidity
- •Pregnancy,lactation or alcohol abuse
- •Patients with poor treatment compliance or could not express themselves correctly
- •Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)
研究组 & 干预措施
minocycline-based bismuth quadruple regimen for 10 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
干预措施: Amoxicillin (Drug)
minocycline-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: Minocycline hydrochloride capsule (Drug)
minocycline-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: Amoxicillin (Drug)
minocycline-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: colloidal bismuth pectin (Drug)
minocycline-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: esomeprazole (Drug)
clarithromycin-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: Clarithromycin (Drug)
clarithromycin-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: Amoxicillin (Drug)
clarithromycin-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: colloidal bismuth pectin (Drug)
clarithromycin-based bismuth quadruple regimen for 14 days
Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
干预措施: esomeprazole (Drug)
minocycline-based bismuth quadruple regimen for 10 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
干预措施: Minocycline hydrochloride capsule (Drug)
minocycline-based bismuth quadruple regimen for 10 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
干预措施: colloidal bismuth pectin (Drug)
minocycline-based bismuth quadruple regimen for 10 days
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
干预措施: esomeprazole (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4-12 weeks after treatment
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy
次要结局
- incidence of adverse effects(3-7 days after treatment)