The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
研究概览
简要总结
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.
详细描述
Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.
- Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
- Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Adults with H.pylori infection.
排除标准
- •Pregnancy,
- •Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
- •Known sensitivity to Urea or citrica.
研究组 & 干预措施
Lansoprazole (Lanton)
Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning
干预措施: Lansoprazole (Lanton) (Drug)
Omeprazole (Losec)
Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning
干预措施: Omeprezole (Losec) (Drug)
Pantoprazole (Controloc)
Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning
干预措施: Pantoprazole(Controloc) (Drug)
Esomeprazole(Nexium)
Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning
干预措施: Esomeprazole (Nexium) (Drug)
结局指标
主要结局
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
时间窗: 17 days
Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB\>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB\<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has \> 96% accuracy.
次要结局
未报告次要终点