POCone-UBiT-IR300 Pediatric Comparison Study
Completed · Phase 4
Conditions studied: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
In brief
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.
Key facts
- Study ID
- NCT01623154
- Run by
- Otsuka America Pharmaceutical
- People needed
- 99
- Starts
- 2012-07-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2015-02-23
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Miami Pediatric Gastroenterology — Miami, Florida, United States
- University of Texas School of Public Health — El Paso, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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