Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
Launched by MERIDIAN BIOSCIENCE, INC. · Dec 9, 2013
Trial Information
Current as of July 06, 2025
Completed
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility criteria
- 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
About Meridian Bioscience, Inc.
Meridian Bioscience, Inc. is a leading global biotechnology company focused on the development and commercialization of innovative diagnostic products and solutions for infectious diseases, gastrointestinal disorders, and other critical health conditions. With a commitment to advancing patient care, Meridian Bioscience leverages cutting-edge technologies and extensive expertise in molecular diagnostics, immunoassays, and life science research. The company's mission is to enhance diagnostic accuracy and efficiency, ultimately improving clinical outcomes and public health. Through rigorous clinical trials and partnerships, Meridian Bioscience aims to deliver reliable and timely diagnostic tools that empower healthcare professionals and patients alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warwick, Rhode Island, United States
Chevy Chase, Maryland, United States
Bronx, New York, United States
Baltimore, Maryland, United States
Jackson, Tennessee, United States
Detroit, Michigan, United States
Ocean Springs, Mississippi, United States
Houston, Texas, United States
Richmond, Virginia, United States
Patients applied
Trial Officials
Melina Arazy, M.D.
Study Director
VP of clinical affairs, Exalenz
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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