The Diagnostic Validity of the Urea Breath Test | NCT02359942

Studies
The Diagnostic Validity of the Urea Breath Test

NCT02359942

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Apr 18, 2019Actual

Enrollment

1,200Actual

Phase

Not Applicable

Conditions

Helicobacter Pylori Infection

Interventions

Citric acid

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2015Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jan 18, 2015

First Submission Date that Met QC Criteria

Feb 4, 2015

First Posted Date

Feb 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2019

Last Update Posted Date

Apr 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nayoung Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).
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

To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
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

Reconfirm inclusion and exclusion criteria
Randomization for UBT test (citric acid group vs control group)
In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
Perform UBT in both group

1-3) Endoscopic surveillance (visit 3, 6 or later months)

Endoscopic surveillance for final H. pylori status after UBT
- Histology, CLOtest or H. pylori culture
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Citric acid	Drug	Giving the citric acid (4g) solving in 200 ml of water before UBT	Citric acid group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seongnam			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D019343	Citric Acid

Ancestor Terms

ID	Term
D002951	Citrates
D014233	Tricarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids

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