Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1200 participants
INTERVENTIONAL
2015-03-01
2018-12-31
Brief Summary
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2. To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.
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Detailed Description
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1. To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
2. 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
1. Reconfirm inclusion and exclusion criteria
2. Randomization for UBT test (citric acid group vs control group)
3. In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
4. Perform UBT in both group
1-3) Endoscopic surveillance (visit 3, 6 or later months)
1. Endoscopic surveillance for final H. pylori status after UBT
* Histology, CLOtest or H. pylori culture
2. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
Study Groups
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Citric acid group
Giving the citric acid (4g) as test meal before UBT
Citric acid
Giving the citric acid (4g) solving in 200 ml of water before UBT
Controlled group
No use of test meal
No interventions assigned to this group
Interventions
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Citric acid
Giving the citric acid (4g) solving in 200 ml of water before UBT
Eligibility Criteria
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Inclusion Criteria
* The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy
Exclusion Criteria
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Nayoung Kim
Professor
Locations
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Seoul National University Hospital
Seongnam, , South Korea
Countries
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Other Identifiers
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B-1412/279-004
Identifier Type: -
Identifier Source: org_study_id
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