Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Rate of eradication success
研究概览
简要总结
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
详细描述
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.
- •Participants who voluntarily want to participate in this study.
排除标准
- •Participants who had history of Helicobacter pylori eradication.
- •Participants who had experience of stomach resection.
- •Participants who had history of allergy or adverse events related to eradication medication.
- •Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.
- •Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate
- •Participants who had history of administration of antibiotics within 4 weeks.
- •Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial
- •Participants who are administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor)
- •Participants who have infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, Torsades de pointes.
研究组 & 干预措施
PAMB group
PAMB treatment (modified quadruple therapy) for 14 days
干预措施: PAMB treatment (modified quadruple therapy) (Drug)
PMBT group
PBMT treatment (bismuth-containing quadruple therapy) for 14 days
干预措施: PBMT treatment (bismuth-containing quadruple therapy) (Drug)
结局指标
主要结局
Rate of eradication success
时间窗: up to 4 weeks
Eradication success means negative urea breath test done at least after 4 weeks from medication administration
次要结局
- Rate of adverse events related to eradication medication(up to 4 weeks)
- Rate of compliance of eradication medication administration(up to 4 weeks)
研究者
Chang Seok Bang
Associate professor of Hallym University College of Medicine
Chuncheon Sacred Heart Hospital