Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
详细描述
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.
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
- 是
入选标准
- •Men and women aged 18 or more including following conditions
- •Family history of gastric cancer
- •Post endoscopic resection status for early gastric cancer or adenoma
- •Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
- •Chronic gastritis
- •Non-ulcer dyspepsia
- •Healthy adults who want to receive H. pylori treatment
- •H. pylori positive by urea breath test, histology, or rapid urease test
排除标准
- •History of H. pylori eradication therapy
- •History of stomach operation
- •Other organ cancer within 5 years
- •Liver cirrhosis or Hepatic insufficiency
- •Renal insufficiency
- •Current treatment for serious medical condition which may hinder participation
- •Contraindication or allergy history for H. pylori treatment regimens
- •Mental incompetence to understand and sign informed consent
- •Incompatible conditions to be included into the trial by investigators' decision
- •Inability to provide an informed consent
- •History of treatment for peptic ulcer disease
研究组 & 干预措施
Standard triple therapy
7 day-PPI based standard triple therapy
干预措施: Standard triple therapy (Drug)
Bismuth quadruple therapy
10 day-bismuth quadruple therapy
干预措施: Bismuth quadruple therapy (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 8 weeks after H. pylori treatment
次要结局
- H. pylori reinfection rate(3 years after success of H. pylori eradication)
- Complications of H. pylori treatment(1 month after H. pylori treatment)
- H. pylori infection status at 1 year after H. pylori treatment(1 year after H. pylori treatment)
- Factors associated with H. pylori reinfection(3 years after success of H. pylori treatment)
- Compliance to H. pylori treatment(1 month)
研究者
Il Ju Choi
Department of gastroenterology, Center for Gastric Cancer
National Cancer Center, Korea