NCT02905825

Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DEVICE	BreathID® Hp System	Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
DRUG	BreathID® Hp Lab System	Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
DIAGNOSTIC_TEST	Stool Test	Each subject was asked to perform a stool test in parallel to the breath test.

Timeline

• Start date: 2017-05-18
• Primary completion: 2017-10-30
• Completion: 2017-11-05
• First posted: 2016-09-19
• Last updated: 2022-12-20
• Results posted: 2018-07-05

Locations

6 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study
• FDA-regulated device study