Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

Inclusion Criteria:

• Present with clinical indication of H. pylori and candidate for upper endoscopy
• Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
• Naive to treatment in the past 18 months
• No known H.pylori status (no conclusive test results within last 6 months)

Exclusion Criteria:

• Participation in other interventional trials
• Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
• PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
• Pregnant or breastfeeding women
• Allergy to test substrates