Study of PyloPlus Urea Breath Test System to Check Safety and Effectiveness in Children Ages 3 to 17 Diagnosing Helicobacter Pylori Infection with Breath and Stool Tests

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the PyloPlus Urea Breath Test System in children aged 3 to 17 who may have Helicobacter pylori infection. This multi-center, open-label study enrolls symptomatic patients on a walk-in basis to compare this new breath test with the standard stool antigen test. The study aims to collect safety data and agreement between tests, supporting diagnosis of H. pylori infection in pediatric patients. Participants will receive a single dose of 13C urea dissolved in water and undergo a breath test using the PyloPlus system, which includes breath collection bags and an analyzer. In addition, a stool antigen test will be conducted at certified labs for comparison. The PyloPlus analyzer results will remain blinded to the treating physician to avoid influencing patient management. The total study duration is about six months. During the study, children will provide breath and stool samples and be monitored for adverse events within 24 hours of testing. Researchers will also assess the agreement between the breath test and the stool antigen test over seven days. No patient management decisions will be made from the investigational test results. This design helps ensure patient safety while gathering data about the tests performance in real-world clinical settings.

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study