The Effect of Citric Acid as the Test Meal on the Diagnostic Accuracy of the 13C-Urea Breath Test in Korean, Randomized Controlled, Open Label Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group
研究概览
简要总结
- To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest and H. pylori culture).
- To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.
详细描述
1-1 Screening (visit 1, From -6 to -8 weeks) and H. pylori eradication
- To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
- H. pylori eradication
- First eradication: PPI-based triple therapy (standard dose of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 1 week), and sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d)
- Rescue therapy: bismuth-containing quadruple therapy [PPI b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.] for 1-2 weeks, or moxifloxacin-containing triple therapy (moxifloxacin 400 mg q.d., amoxicillin 1g b.i.d., and PPI b.i.d.) for 1-2 weeks.
1-2 Baseline (visit 2, 0 week): urea breath test
- Reconfirm inclusion and exclusion criteria
- Randomization for UBT test (citric acid group vs control group)
- In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
- Perform UBT in both group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female Korean adult (Aged over 18 years)
- •The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy
排除标准
- •Age under 18 years
- •Patients who took any drug which could affect the study results such as proton pump inhibitor, H2 blocker, mucosal protective agents and antibiotics
- •Advanced gastric cancer or other malignancy
- •Abnormal liver function test or liver cirrhosis
- •Abnormal renal function or chronic kidney disease
- •Other severe concurrent disease
研究组 & 干预措施
Citric acid group
Giving the citric acid (4g) as test meal before UBT
干预措施: Citric acid (Drug)
结局指标
主要结局
Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group
时间窗: 6 months or later after urea breath test
After urea breath test in the two group (citric acid group vs controlled group), endoscopic surveillance would be performed for confirmation of H. pylori status by endoscopic biopsy methods(histology, CLOtest or culture).
Compare the diagnostic accuracy which is a composite outcome measure such as sensitivity, specificity, predictive positive value and negative predictive value between citric acid group and controlled group
时间窗: 6 months or later after urea breath test
Comparing the final H. pylori status between UBT method and endoscopic biopsy methods, we will evaluate the diagnostic accuracy (sensitivity, specificity, false positive ratio, false negative ratio, positive predictive value and negative predictive value) of the UBT between using citric acid group and controlled group.
次要结局
未报告次要终点
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital