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

Meridian Bioscience

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: BreathID® Hp Lab System; Device: BreathID® Hp System; Diagnostic Test: Stool Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02905825

PED-HP-0616B

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Indication for Helicobacter pylori testing

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Stool Test

Device: BreathID® Hp System

Drug: BreathID® Hp Lab System