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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02010112
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Other: Breath Test Collection bags Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Initial Diagnosis Cohort
Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
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
Other Name: IDKit Two

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02010112

United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48377
United States, Mississippi
Digestive Health Care
Ocean Springs, Mississippi, United States, 39564
United States, New York
Montefiore Hospital
Bronx, New York, United States, 10467
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Clinical Research Solutions
Jackson, Tennessee, United States, 38305
United States, Texas
JM Research
Houston, Texas, United States, 77011
United States, Virginia
Bon Secours Health System
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Exalenz Bioscience LTD.
Study Director: Melina Arazy, M.D. VP of clinical affairs, Exalenz

Responsible Party: Exalenz Bioscience LTD. Identifier: NCT02010112     History of Changes
Other Study ID Numbers: DM-MPBA-0813
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Exalenz Bioscience LTD.:

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections