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

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