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

• Status: Completed
• Trial end date: 2017-11-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exalenz Bioscience LTD.

Criteria

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