Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial

Indonesia University1 个研究点分布在 1 个国家目标入组 73 人开始时间: 2016年10月3日最近更新: 2017年4月28日

适应症

干预措施

试验速览

阶段: 4 期
发起方: Indonesia University
入组人数: 73
试验地点: 1
主要终点: Eradication of Helicobacter pylori infection

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple therapy with longer duration will provide a higher percentage of eradication. This study wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter pylori eradication.

详细描述

This is a double-blinded randomized clinical trials, to determine the proportion of eradication of Helicobacter pylori infection using a triple therapy regimen for 10 days and 14 days. The triple therapy regimen was a proton pump inhibitor (Rabeprazole 20 mg twice daily), Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.

Patients with dyspepsia and no improvement for at least 2 weeks with empiric therapy (lifestyle education, antacid, H2-antagonist, or proton pump inhibitor), are further investigated to determine the presence of Helicobacter pylori infection using invasive (Esophagoduodenoscopy/EGD) or non-invasive methods (Urea Breath Test/UBT).

Patients with positive results on UBT or histology examination from EGD and fulfill inclusion and exclusion criteria are included as research subjects, then randomly assigned to determine the subject of the study into the sample of study entry in group 1 or group 2.

All subjects will be required to fill out informed consent, demographic data, anthropometric measurements, and questionnaires.

Research subjects will get triple therapy regimen for Helicobacter pylori infection in the form of Proton Pump Inhibitor (Rabeprazole 2 x 20 mg), Amoxicillin 2 x 1000 mg, and Clarithromycin 2 x 500 mg.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Randomized-double blinded Clinical Trials

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

•18 years or older patients who are proven to be infected by Helicobacter pylori based on positive in Urea Breath Test or positive in histopathologic examination of biopsy in antrum and corpus of gaster through esophagoduodenoscopy.

排除标准

•Patients refuse to follow the research
•Patient has had previous eradication therapy of Helicobacter pylori infection.
•The patient is pregnant or breastfeeding
•Patients have a history of allergy to one component of triple therapy regimen (proton pump inhibitor, penicillin, and / or macrolide) before.
•Patients are known to have impaired liver function, evidenced by ALT values within normal limits, and no previous liver disease.
•Patients were found to have arrhythmias or obtained QT wave elongation on electrocardiographic