Helicobacter Pylori Infection Clinical Trial
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
Verified date | April 2019 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
1. 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).
2. To compare the delta value of 13CO2 results between before and after ingestion of citric
acid as test meal.
Status | Completed |
Enrollment | 1200 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Male and female Korean adult (Aged over 18 years) - The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seongnam |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group | 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). | 6 months or later after urea breath test | |
Primary | 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 | 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. | 6 months or later after urea breath test |
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