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

Phase 3

Completed

Interventions: Device: BreathID® Hp System
Drug: BreathID® Hp Lab System
Diagnostic Test: Stool Test

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Indication for Helicobacter pylori testing	BreathID® Hp System	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.
Indication for Helicobacter pylori testing	BreathID® Hp Lab System	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.
Indication for Helicobacter pylori testing	Stool Test	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Reported Adverse Events	24 hours	Number of participants with reported adverse events after performing urea breath test

Secondary Outcome Measures

Name	Time	Method
Percentage of Agreement	1 week	Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection

Locations (6): Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
🇺🇸
Shreveport, Louisiana, United States
Children's Health - Children's Medical Center Dallas (UT Southwestern)
🇺🇸
Dallas, Texas, United States
Gastrointestinal Associates
🇺🇸
Flowood, Mississippi, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸
Nashville, Tennessee, United States
Assaf Harofe Medical Center
🇮🇱
Tzrifin, Israel
Baylor College of Medicine/Texas Children's Hospital
🇺🇸
Houston, Texas, United States