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Completed

NCT Number: NCT02010112

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Digestive Disease Associates, PA, Baltimore, Maryland, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath Test Collection bags

Other

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

Other names: IDKit Two

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2013
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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