CompletedPhase 4

POCone-UBiT-IR300 Pediatric Comparison Study

United States99 participantsStarted 2012-07

Plain-language summary

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.

Who can participate

Age range3 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Agreement Between POCone and UBiT-IR300.

Timeframe: Baseline, Post Dose (15 min)

Trial details

NCT IDNCT01623154

SponsorOtsuka America Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2014-04-29

View on ClinicalTrials.gov More Bacterial Infection Due to Helicobacter Pylori (H. Pylori) trials