PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Study Overview
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Brief Summary
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This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample. Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System. Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician. Total duration of study is anticipated to be approximately 6 months.

Official Title
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PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Conditions
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Helicobacter Pylori, Safety, Efficacy

Intervention / Treatment
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* Combination Product: PyloPlus Urea Breath Test System
* Diagnostic Test: Stool Antigen Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 3-17 at the time of visit Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form Naive to H. pylori treatment in the past 4 weeks Exclusion Criteria: Pregnant and/or lactating women Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data Participation in other interventional trials Allergy to test substrates Antibiotics taken within 4 weeks of the testing Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 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: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indication for H. pylori testing<br>Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison. | Combination Product: PyloPlus Urea Breath Test System<br>* System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.<br>Diagnostic Test: Stool Antigen Test<br>* An antigen test performed via a laboratory to test patients' stool for H. pylori<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recorded adverse events | Number of participants with recorded 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 | 7 days |