Clinical trial NCT02359942: The Diagnostic Validity of the Urea Breath Test
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori infection
Eradication
Urea breath test
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group
timeFrame: 6 months or later after urea breath test
measure: 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
timeFrame: 6 months or later after urea breath test
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: