Additive Effect of Endonase on the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori
排除标准
- •Patients Under 18 years, OR
- •Patients with active peptic ulcer, OR
- •Pregnant or Breast feeding women, OR
- •Patients with gastric malignancy, OR
- •Patients with a history of drug allergy or hypersensitivity, OR
- •Patients with severe renal, liver, or heart diseases
研究组 & 干预措施
with Endonase
Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] plus 20,000 units of pronase (endonase), BID for 7 days
干预措施: Second-line quadruple therapy with endonase (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4 weeks
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the bismuth-containing quadruple therapy plus endonase as the second-line treatment with that of the bismuth-containing quadruple therapy
次要结局
- Number of participants with adverse events(4 weeks)
- Number of participants taking over 85% of medicine(4 weeks)
研究者
Yeonsoo Kim
Assistant Professor
Chuncheon Sacred Heart Hospital