Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
54
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
Each subject was asked to perform a stool test in parallel to the breath test.
Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Gastrointestinal Associates
Flowood, Mississippi, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Health - Children's Medical Center Dallas (UT Southwestern)
Dallas, Texas, United States
Number of Participants With Reported Adverse Events
Number of participants with reported adverse events after performing urea breath test
Time frame: 24 hours
Percentage of Agreement
Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
Time frame: 1 week
Percentage of Agreement
Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Assaf Harofe Medical Center
Tzrifin, Israel