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

Status:	Completed
Conditions:	Infectious Disease, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2014
End Date:	February 2015

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

We found this trial at

sites

Digestive Disease Associates, PA

Baltimore, Maryland 21229

from

Baltimore, MD