Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication
研究概览
简要总结
This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.
详细描述
Helicobacter pylori (H. pylori) is a spiral-shaped, Gram-negative bacterium that colonizes the stomach lining and is considered one of the most prevalent chronic infections globally.
Bismuth-based quadruple therapy (proton pump inhibitor, bismuth, metronidazole, and tetracycline) is considered an effective alternative in cases of antibiotic resistance. This regimen achieves high eradication rates, even in areas with dual clarithromycin and metronidazole resistance.
Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.
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
- •Adults aged ≥18 years.
- •Both sexes.
- •Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).
- •No prior eradication therapy.
排除标准
- •Prior Helicobacter pylori treatment.
- •Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.
- •Gastric surgery history.
- •Major organ failure.
- •Pregnancy or lactation.
- •Known allergy to study drugs.
研究组 & 干预措施
B-CAP group
Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.
干预措施: Potassium-Competitive Acid Blocker (Drug)
PPI group
Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.
干预措施: Proton Pump Inhibitor (Drug)
结局指标
主要结局
Helicobacter pylori eradication
时间窗: 2 weeks after proton pump inhibitor
Helicobacter pylori eradication rate will be recorded.
次要结局
- Adverse drug reactions(2 weeks after proton pump inhibitor)
- Patient adherence(2 weeks after proton pump inhibitor)
- Degree of patient satisfaction(2 weeks after proton pump inhibitor)
研究者
Mohamed Galal Flefel
Lecturer of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University