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

PED-HP-0616B

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

2017-05-18

2017-10-30

2017-11-05

Completed

Early phase I

54

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2022-12-20