CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 54 enrolled
Drug / intervention
BreathID® Hp Lab System +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02905825
NCT02905825Phase 3Completed
CompareCT.gov

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

Meridian Bioscience, Inc.·interventional·Posted Sep 19, 2016·Updated Dec 20, 2022

In Brief

A Phase 3 clinical trial evaluating BreathID® Hp System, BreathID® Hp Lab System, and 1 other intervention for Helicobacter Pylori Infection. Completed, enrolled 54 participants across 6 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesIsrael, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 19, 2016
Enrollment StartMay 18, 2017
Primary CompletionOct 30, 2017
Study CompletionNov 5, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.8 years ago

Interventions

BreathID® Hp Systemdevice

Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab Systemdrug

Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Stool Testother

Each subject was asked to perform a stool test in parallel to the breath test.