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临床试验/CTRI/2026/01/100661
CTRI/2026/01/100661尚未招募Unknown

Comparison of Vonoprazan dual therapy with Vonoprazan Bismuth-based triple therapy in Helicobacter pylori eradication – A Randomized Controlled Trial

Government Kilpauk Medical college1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
140
试验地点
1

研究概览

简要总结

Helicobacter pylori is a gram negative bacterium that colonizes the gastric mucosa and is a major cause of chronic gastritis peptic ulcer disease MALT lymphoma and gastric adenocarcinoma. Eradication of H pylori reduces disease related complications and is a key component of gastrointestinal disease management. However increasing antibiotic resistance poor compliance and inadequate acid suppression with proton pump inhibitors have reduced treatment success rates.

Vonoprazan is a potassium competitive acid blocker that provides rapid and sustained gastric acid suppression and is not affected by CYP2C19 genetic variability. It has shown superior or comparable efficacy to proton pump inhibitor based regimens in H pylori eradication. Vonoprazan has been approved in India in May 2024 as an adjuvant for H pylori eradication.

Although vonoprazan based dual therapy and vonoprazan based bismuth regimens have demonstrated high eradication rates direct randomized comparisons between these regimens are limited. Differences in antibiotic exposure tolerability and adherence warrant systematic evaluation.

This randomized controlled trial PILL-B Trial ( Potassium-competitive acid blocker (vonoprazan) In Low-pilL burden with Bismuth vs dual therapy)aims to compare the efficacy and safety of vonoprazan dual therapy versus vonoprazan bismuth triple therapy for eradication of H pylori infection. Secondary objectives include assessment of treatment adherence and adverse event profile.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18 to 70 years Confirmed H pylori infection by Rapid Urease Test Treatment Naive for H pylori.

排除标准

  • Known Allergy to study drugs Previous H pylori eradication therapy Pregnancy or lactation Patients on NSAIDS Severe hepatic or renal impairment.

研究者

发起方
Government Kilpauk Medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Harrison Gabriel G B

Government Kilpauk Medical college

研究点 (1)

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