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CompletedNCT02359942Updated Apr 18, 2019

The Diagnostic Validity of the Urea Breath Test

An interventional study of Citric acid in Helicobacter Pylori Infection, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.
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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.
  1. 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.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Helicobacter pylori infection
  • Eradication
  • Urea breath test
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,200 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
1,200 participants (actual)

Study arms

  • Experimental
    Citric acid group

    Giving the citric acid (4g) as test meal before UBT

    Drug: Citric acid

  • No intervention
    Controlled group

    No use of test meal

Interventions

  • DrugCitric acid

    Giving the citric acid (4g) solving in 200 ml of water before UBT

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months or later after urea breath test

  2. 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.

    Time frame: 6 months or later after urea breath test

07

Study locations

1 site
  • Seoul National University Hospital
    Seongnam, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02359942
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Nayoung Kim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Feb 10, 2015
Start date
Mar 1, 2015
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Apr 18, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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