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

Phase 3CompletedNCT02010112

Meridian Bioscience, Inc.193 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

193

Conditions

Helicobacter Pylori Infection

Interventions

Breath Test Collection bagsOTHER

Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Digestive Disease Associates, PA

Baltimore, Maryland, United States

Metropolitan Gastroenterology Group

Chevy Chase, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Digestive Health Care

Outcomes

Primary Outcomes

overall percent agreement

The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.

Time frame: 21 days

Secondary Outcomes

overall percent agreement

The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results

Time frame: 21 days

Data from ClinicalTrials.gov

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