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

NCT02905825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-12-20

Study results available
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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

Conditions

  • Helicobacter Pylori Infection

Interventions

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.

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2017-10-30
Completion
2017-11-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02905825 on ClinicalTrials.gov