Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- H. pylori eradication rates
研究概览
简要总结
Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.
详细描述
The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.
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
BID group
Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days
干预措施: Amoxicillin (Drug)
QID group
Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid for 14 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
H. pylori eradication rates
时间窗: 6 weeks
Urea breath test after completing H. pylori eradication regimen
次要结局
- Drug-related adverse event rate(6 weeks)
- Treatment compliance(6 weeks)
研究者
Jun-Hyung Cho
Professor
Soonchunhyang University Hospital
