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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 2015

Detailed 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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Initial Diagnosis Cohort
    • Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy

Clinical Trial Outcome Measures

Primary Measures

  • overall percent agreement
    • Time Frame: 21 days
    • 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.

Secondary Measures

  • overall percent agreement
    • Time Frame: 21 days
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Meridian Bioscience, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Melina Arazy, M.D., Study Director, VP of clinical affairs, Exalenz

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