A Comparison Study of Helicobacter Pylori Eradication Rates Between Daily Four Times and Daily Two Times Usage of Proton Pump Inhibitor and Amoxicillin for the First Line and the Second Line Eradication Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
The hypothesis and plan of the current study are:
- One induction phase of high dose PPI before eradication will increase intragastric pH and induce H. pylori into an active replicative status. Active replicative status will enhance the bactericidal effect of amoxicillin. Rabeprazole (20 mg) four times per day (qid) for 3 days will be used for induction in this study.
- High dose PPI will provide adequate plasma concentration irrespective of the CYP2C19 genotype of the population. Here rabeprazole (20 mg) qid will be applied as high dose PPI.
- High frequent amoxicillin usage (500 mg, qid) will maintain plasma concentration above the MIC. Amoxicillin (500 mg) qid will be described for total 14 days.
- In the rescue therapy, add levofloxacin on high dose dual therapy will increase the eradication rate than single high dose dual therapy. A combination of levofloxacin and high dose dual therapy will also have a better eradication rate than the common used levofloxacin based triple therapy.
详细描述
This study aims to evaluate:
- the first line H. pylori eradication rate of high dose dual therapy with 14 days rabeprazole 20 mg qid, plus amoxicillin 500 mg qid (HDDT group) comparing to the clarithromycin-based triple therapy with 14 days clarithromycin 500 mg bid, amoxicillin 1000mg bid , and rabeprazole 20mg bid (CATT group).
- the eradication efficacy in rescue therapy of a levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 500 mg qid and rabeprazole 20 mg qid (LHDT group) comparing to the common levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 1000mg bid and rabeprazole 20 mg (LATT group).
Material and Methods Patients and study design This is a prospective, randomized, open-label trial. The patients diagnosed with H. pylori infection will be enrolled from Jan 2019 to Dec 2020 in Keelung Chang-Gung Memorial hospital. The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD). Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study. Patients without previous H. pylori eradication therapy are invited to receive the first-line regimens, whereas patients who have previously received H. pylori eradication therapy are invited to receive rescue regimens.
Hospital patients are asked to receive five endoscopic biopsy specimens (3 from gastric antrum and 2 from body mucosa) for rapid urease test (RUT) and culture studies. The definition of H. pylori infection is a positive finding from UBT, RUT or culture.
Diagnosis for H. pylori infection RUT Three specimens from endoscopic biopsy are used for the RUT (HelicotecUT ® plus test; Strong Biotech Corporation, Taipei, Taiwan). The test result will be read one hour later. A medium color change from yellowish to pink or red is recorded as a positive finding for H. 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD).
排除标准
- •Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study.
研究组 & 干预措施
HDDT group
high dose PPI induction (oral rabeprazole 20mg qid) for 3 days, then 14 days combined with amoxicillin (regular dose, daily 2 g, 500mg qid) for high frequency dual therapy.
干预措施: Rabeprazole (Drug)
CATT group
conventional triple therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid)
干预措施: Rabeprazole (Drug)
LHDT group
high dose PPI (oral rabeprazole 20mg qid) induction for 3 days, then Rabeprazole 20 mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd for 14 days.
干预措施: Rabeprazole (Drug)
LATT group
levofloxacin base rescue therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, levofloxacin 500 mg qd)
干预措施: Rabeprazole (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 2~3 months
Two to three months after eradication therapy, urea breath test will be performed. If the result of UBT is negative, it means successful eradication. If the result is positive, it means eradicaiton failure
次要结局
未报告次要终点
研究者
Li-Wei Chen
chief, division of hepato-gastroenterology
Chang Gung Memorial Hospital