POCone-UBiT-IR300 Pediatric Comparison Study

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

• Male or female subject ages 3 to 1711/12 years.
• Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.)
• Subject and/or parent/legal guardian is capable of giving assent or consent.
• Subject is able to complete the urea breath test by investigator's assessment.

Exclusion criteria

• Subject is hypersensitive to mannitol, citric acid and/or aspartame.
• Previous diagnosis of phenylketonuria (PKU.
• Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions.
• Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples.
• Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.)
• Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing.
• Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing.
• Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing.
• Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing.
• Treatment for eradication of H pylori within 28 days before testing or retesting.
• Participation in a drug or device study within 30 days of testing