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

Completed · Phase 3

Conditions studied: Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID: NCT02010112
Run by: Meridian Bioscience, Inc.
People needed: 193
Starts: 2014-01-01
Expected to finish: 2015-02-01
Last updated by the study team: 2022-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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