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

Meridian Bioscience

Status and phase

Completed

Phase 3

Conditions

Helicobacter Pylori Infection

Treatments

Other: Breath Test Collection bags

Study type

Interventional

Funder types

Industry

Identifiers

NCT02010112

DM-MPBA-0813

Details and patient eligibility

About

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.

Full description

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

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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