The Diagnostic Validity of the Urea Breath Test

NCT02359942 | Completed

• 1 other identifier: B-1412/279-004
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection; Eradication; Urea breath test

Outcome Measures

Primary Outcomes (2)

• 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).

  6 months or later after urea breath test

• 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.

  6 months or later after urea breath test

Study Arms (2)

Citric acid group

EXPERIMENTAL

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

Drug: Citric acid

Controlled group

NO INTERVENTION

No use of test meal

Interventions

Citric acid DRUG

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

Citric acid group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female Korean adult (Aged over 18 years)
• The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seongnam, South Korea

Location

MeSH Terms

Interventions

Citric Acid

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: February 10, 2015
• Study Start: March 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

KR (1)