NCT02359942

The Diagnostic Validity of the Urea Breath Test

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

1-1 Screening (visit 1, From -6 to -8 weeks) and H. pylori eradication 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

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Citric acid	Giving the citric acid (4g) solving in 200 ml of water before UBT

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-02-10
• Last updated: 2019-04-18

Locations

1 site across 1 country: South Korea