Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Diagnostic Validity of the Urea Breath Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02359942
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Citric acid Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Citric acid group
Giving the citric acid (4g) as test meal before UBT
Drug: Citric acid
Giving the citric acid (4g) solving in 200 ml of water before UBT

No Intervention: Controlled group
No use of test meal



Primary Outcome Measures :
  1. Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group [ Time Frame: 6 months or later after urea breath test ]
    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).

  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 [ Time Frame: 6 months or later after urea breath test ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359942


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital

Layout table for additonal information
Responsible Party: Nayoung Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02359942     History of Changes
Other Study ID Numbers: B-1412/279-004
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Helicobacter pylori infection
Eradication
Urea breath test

Additional relevant MeSH terms:
Layout table for MeSH terms
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action