Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Meridian Bioscience, Inc.
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.
Age
3–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
