Increased Second-line Eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Conventional Triple Therapy.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Re-eradication rate
研究概览
简要总结
Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole, clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter pylori infection.
详细描述
Background: Antimicrobial resistance has decreased the eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%). Such treatment for patient previously with treatment failure, the retreatment eradication rate is less then 50%. Some studies showed the Helicobacter pylori form biofilm to prevent entry of antibiotics, and the N-acetylcystein is helpful to dissolve the biofilm.
Objective: To determine the eradication rate of the common used triple therapy after adding N-acetylcystein for second line treatment for adults infected with Helicobacter pylori in Eastern Taiwan.
Design: Randomized, open-label, prospective controlled trial.
Patients: who are previously failed the primary treatment for eradication and still infected by Helicobacter pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient after treatment for Helicobacter pylori eradication.
- •Still clinically with evidence of gastric Helicobacter pylori infection.
排除标准
- •woman in breast feeding or pregnancy.
- •allergy to drugs used in study.
- •never treated for H. pylori.
- •intolerance to fructose, lactose.
- •patients with hematologic, brain or spinal disorders.
- •patients under 20 years old.
- •patients with malignancy or with decompensated function of vital organs.
研究组 & 干预措施
Acetylcystein
10-day triple therapy plus N-acetyl-cystein to remove the biofilm.
干预措施: 10RAC+acetylcystein (Drug)
Metronidazole
10-day triple therapy plus metronidazole (concomitant therapy) as active comparator
干预措施: 10RAC+metronidazole (Drug)
结局指标
主要结局
Re-eradication rate
时间窗: 4 weeks after complete use of drug for treatment
A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.
次要结局
- Influence of Participant's CYP2C19 genotype on re-eradication rate(4 weeks after complete use of drug for treatment)
研究者
Ming-Cheh Chen
Principal Investigator
Buddhist Tzu Chi General Hospital