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

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.

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