POCone-UBiT-IR300 Pediatric Comparison Study
POCone-UBiT-IR300 Pediatric Comparison Study
The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring
 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath
 test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in
 pediatric subjects.
The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test
 positive for H. pylori, they will be given eradication medication and brought back in for a
 re-test.
Inclusion Criteria:

 1. Male or female subject ages 3 to 1711/12 years.

 2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal
 pain/discomfort, bloating, nausea, or vomiting, etc.)

 3. Subject and/or parent/legal guardian is capable of giving assent or consent.

 4. Subject is able to complete the urea breath test by investigator's assessment.

 Exclusion Criteria:

 1. Subject is hypersensitive to mannitol, citric acid and/or aspartame.

 2. Previous diagnosis of phenylketonuria (PKU.

 3. Subject with difficulty swallowing or who may be at high risk for aspiration due to
 medical or physical conditions.

 4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise
 the collection of breath samples.

 5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney
 diseases, etc.)

 6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days
 prior to the testing.

 7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole,
 clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the
 testing.

 8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole,
 lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14
 days prior to the testing.

 9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine,
 cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the
 testing.

 10. Treatment for eradication of H pylori within 28 days before testing or retesting.

 11. Participation in a drug or device study within 30 days of testing