Clinical TrialID 5431
The Diagnostic Validity of the Urea Breath Test
NCT02359942
Helicobacter Pylori Infection
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5431
- Evidence Id
- 5431
- Core Evidence Id
- 5431
- Source Clinical Trial Id
- 5417
- Herb2 Clinical Trial Id
- HBCT005417
- Nct Id
- NCT02359942
- Title
- The Diagnostic Validity of the Urea Breath Test
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Helicobacter Pylori Infection
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: |Primary Purpose: DIAGNOSTIC
- Intervention
- DRUG: Citric acid
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Diagnostic
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 1200
- Outcome Measure
- 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|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
- Sponsor Collaborator
- Seoul National University Bundang Hospital
- Funded By
- OTHER
- Location
- Seoul National University Hospital, Seongnam, Korea, Republic of
- Other Id
- B-1412/279-004
- Start Date
- 2015-03-01
- Primary Completion Date
- 2018-12-31
- Completion Date
- 2018-12-31
- First Posted
- 2015-02-10
- Results First Posted
- Last Update Posted
- 2019-04-18
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02359942
- Title Cn
- Title En
- The Diagnostic Validity of the Urea Breath Test
- Bilingual Status
- semi_complete