POCone-UBiT-IR300 Pediatric Comparison Study

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