Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- H.pylori eradication
研究概览
简要总结
This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori
详细描述
The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years of both genders.
- •Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
- •Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
- •Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
- •Patients signing an informed consent.
排除标准
- •Patients refusing to sign an informed consent.
- •Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
- •Patients who have chronic debilitating and advanced systemic diseases.
- •Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
- •Any lactating or pregnant female.
研究组 & 干预措施
Arm 1 Vonoprazn Triple Therapy Arm
Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily[BID]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days
干预措施: Vonoprazan (Drug)
Arm 2 Proton Pump Inhibitor Triple Therapy Arm
Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days
干预措施: Vonoprazan (Drug)
Arm 3 Vonoprazan Quadruple Therapy Arm
Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily[OD] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days.
干预措施: Vonoprazan (Drug)
Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm
Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days
干预措施: Vonoprazan (Drug)
结局指标
主要结局
H.pylori eradication
时间窗: six weeks
The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.
次要结局
- Safety of Vonoprazan use(six weeks)
研究者
Reda Elwakil
Emeritus Professor
Ain Shams University