Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
NCT ID: NCT02010112
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2014-01-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Initial Diagnosis Cohort
Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Meridian Bioscience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Melina Arazy, M.D.
Role: STUDY_DIRECTOR
VP of clinical affairs, Exalenz
Locations
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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
Ocean Springs, Mississippi, United States
Montefiore Hospital
The Bronx, New York, United States
Omega Medical Research
Warwick, Rhode Island, United States
Clinical Research Solutions
Jackson, Tennessee, United States
JM Research
Houston, Texas, United States
Bon Secours Health System
Richmond, Virginia, United States
Countries
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Other Identifiers
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DM-MPBA-0813
Identifier Type: -
Identifier Source: org_study_id