The Diagnostic Validity of the Urea Breath Test
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|ClinicalTrials.gov Identifier: NCT02359942|
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 18, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Citric acid||Not Applicable|
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
1-3) Endoscopic surveillance (visit 3, 6 or later months)
Endoscopic surveillance for final H. pylori status after UBT
- Histology, CLOtest or H. pylori culture
- Statical analysis for diagnostic accuracy of the UBT between citric acid group and controlled group: sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, and false negative rate.
2. Selecting 40 patients who showed UBT result between 2.5 to 4.0 in controlled group, the investigators are planning to reperform 13C-UBT after giving citric acid as test meal.
And then, the investigators compare the change of UBT result before and after ingestion citric acid as test meal.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Citric acid group
Giving the citric acid (4g) as test meal before UBT
Drug: Citric acid
Giving the citric acid (4g) solving in 200 ml of water before UBT
No Intervention: Controlled group
No use of test meal
- Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359942
|Korea, Republic of|
|Seoul National University Hospital|
|Seongnam, Korea, Republic of|