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

This study has been completed.
Information provided by (Responsible Party):
Exalenz Bioscience LTD. Identifier:
First received: December 5, 2013
Last updated: March 16, 2015
Last verified: March 2015
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 Intervention Phase
Helicobacter Pylori Infection
Other: Breath Test Collection bags
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • overall percent agreement [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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:
  • overall percent agreement [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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

Enrollment: 193
Study Start Date: January 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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: Dan Peres, M.D. Exalenz Bioscience Director of Clinical Affairs
  More Information

No publications provided

Responsible Party: Exalenz Bioscience LTD. Identifier: NCT02010112     History of Changes
Other Study ID Numbers: DM-MPBA-0813
Study First Received: December 5, 2013
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Exalenz Bioscience LTD.:

Additional relevant MeSH terms:
Helicobacter Infections
Bacterial Infections
Gram-Negative Bacterial Infections processed this record on November 27, 2015