Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- H. pylori infection status
研究概览
简要总结
Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.
Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.
详细描述
The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroscopy can be performed
- •H. pylori test and pathological analysis can be performed
排除标准
- •Age < 20 or > 80 years
- •Anemia (serum hemoglobin level < 10 g/dL)
- •Severe systemic disease
- •Advanced chronic liver disease
- •Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- •History of H. pylori eradication
- •Drug allergy to antibiotics
- •History of gastric surgery
- •Recent history of upper gastrointestinal bleeding
研究组 & 干预措施
Non-bismuth group
Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days
干预措施: H. pylori eradication (Drug)
Bismuth group
Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days
干预措施: H. pylori eradication (Drug)
结局指标
主要结局
H. pylori infection status
时间窗: 6 weeks
Rate of successful H. pylori eradication
次要结局
未报告次要终点
研究者
Jun-Hyung Cho
Associate Professor
Soonchunhyang University Hospital