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临床试验/CTRI/2025/11/097362
CTRI/2025/11/097362尚未招募不适用

Comparative Effectiveness And Safety Of Different PCAB Based Triple Therapy Regimens For Helicobacter Pylori Eradication

Dr Naresh Agrawal1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年11月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1

研究概览

简要总结

Helicobacter pylori (H pylori) is a gram negative bacterium that colonizes the gastric mucosa and plays a central role in the pathogenesis of chronic gastritis peptic ulcer disease mucosa associated lymphoid tissue (MALT) lymphoma and gastric cancer Eradication of H pylori is critical not only for symptom relief but also for long term prevention of serious gastrointestinal complications

Traditional eradication regimens are based on proton pump inhibitor (PPI)based triple therapy which includes a PPI amoxicillin and clarithromycin However rising antibiotic resistance particularly to clarithromycin and metronidazole has reduced the efficacy of these standard therapies often dropping success rates below 80

To overcome these limitations newer agents like potassium competitive acid blockers (PCABs)notably vonoprazan have been introduced These provide stronger and more sustained acid suppression improving the gastric environment for antibiotic action Modified regimens such as vonoprazan based dual triple and quadruple therapies have demonstrated superior eradication rates particularly in resistant populations

The choice of eradication regimen depends on local antibiotic resistance patterns previous treatment history and patient specific factors such as allergies and tolerability Ongoing research is focused on optimizing treatment duration drug combinations and the use of novel acid suppressants like fexuprazan which remains under investigation

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 65 years Confirmed H pylori infection by endoscopy rapid urease test (RUT) Urea breath test.

排除标准

  • Prior H pylori eradication therapy within 6 months Allergy or intolerance to any study drugs Antibiotic or PPI use within 4 weeks prior to enrolment Pregnancy or lactation Severe liver kidney or cardiovascular disease neurological or oncological disease History of gastric surgery or malignancy.

研究者

发起方
Dr Naresh Agrawal
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Naresh Agarwal

Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre)

研究点 (1)

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