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

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 Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Device: BreathID® Hp System; Drug: BreathID® Hp Lab System; Diagnostic test: Stool Test

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Tzrifin, Israel, 70300
    • Assaf Harofe Medical Center
• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71118
      • Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Gastrointestinal Associates
  • Tennessee
    • Nashville, Tennessee, United States, 10238
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Health - Children's Medical Center Dallas (UT Southwestern)
    • Houston, Texas, United States, 77094
      • Baylor College of Medicine/Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be older than 3 and younger than 18 years of age
• Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
• Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
• Naïve to H. pylori treatment in the past 6 weeks

Exclusion Criteria:

• Participation in other interventional trials
• PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
• Pregnant or breastfeeding female
• Allergy to test substrates
• Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
• Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
• Exposure to any 13C-enriched substance 24 hours prior to the breath test.
• Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
• Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Indication for Helicobacter pylori testing; Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.

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.; Other Names: Stool Antigen Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reported Adverse Events	Number of participants with reported adverse events after performing urea breath test	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Agreement	Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection	1 week
Percentage of Agreement	Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection	1 week

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): November 5, 2017

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PED-HP-0616B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes