NCT02010112

Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

Detailed description

This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
OTHER	Breath Test Collection bags	Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-12-12
• Last updated: 2022-12-20

Locations

9 sites across 1 country: United States