Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

Study Overview
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Brief Summary
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Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Detailed Description
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Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.

Official Title
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Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Device: BreathID® Hp System
* Drug: BreathID® Hp Lab System
* Diagnostic Test: Stool Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be older than 3 and younger than 18 years of age Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori) Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form Naïve to H. pylori treatment in the past 6 weeks Exclusion Criteria: Participation in other interventional trials PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test Pregnant or breastfeeding female Allergy to test substrates Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test. Exposure to any 13C-enriched substance 24 hours prior to the breath test. Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indication for Helicobacter pylori testing<br>Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. | Device: BreathID® Hp System<br>* Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea<br>Drug: BreathID® Hp Lab System<br>* Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea<br>Diagnostic Test: Stool Test<br>* Each subject was asked to perform a stool test in parallel to the breath test.<br>* Other names: Stool Antigen Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reported Adverse Events | Number of participants with reported adverse events after performing urea breath test | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Agreement | Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection | 1 week | 
| Percentage of Agreement | Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection | 1 week |