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临床试验/NCT06950489
NCT06950489已完成不适用

A Feasibility Study of Tegoprazan and Amoxicillin Dual Therapy for the Treatment of Helicobacter Pylori

Soonchunhyang University Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
H. pylori eradication rates

研究概览

简要总结

Dual therapy for Helicobacter pylori refers to a treatment regimen that combines two agents: a potent acid suppressor (such as a proton pump inhibitor [PPI] or a potassium-competitive acid blocker [PCAB]) and the antibiotic amoxicillin. This approach is increasingly recognized as a viable alternative to traditional triple or quadruple therapies, particularly in the context of rising resistance to other antibiotics such as clarithromycin and metronidazole. Potent acid suppression increases the stability and activity of amoxicillin against H. pylori by maintaining a higher gastric pH, which is essential for optimal amoxicillin effect. High-dose dual therapy (e.g., amoxicillin 1,000 mg three times daily + standard dose of PPI three or four times daily for 14 days) has demonstrated eradication rates of 90%. In 2015, vonoprazan, a novel P-CAB, was launched in Japan and used as an alternative for PPIs for eradicating H. pylori. Dual therapy with vonoprazan and amoxicillin is particularly effective, with cure rates comparable to triple therapy and superior outcomes in clarithromycin-resistant infections. Dual therapy is generally well tolerated, with adverse event rates similar to or lower than those seen with triple or quadruple regimens. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for H. pylori eradication. However, there was no study of tegoprazan and amoxicillin dual therapy for the treatment of H. pylori.

详细描述

The investigators aim to evaluate the H. pylori eradication success rate and treatment compliance of tegoprazan and amoxicillin dual therapy.

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

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

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

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Hyung Cho

Professor

Soonchunhyang University Hospital

研究点 (2)

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