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Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

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: NCT01650831
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : September 2, 2013
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Brief Summary:
The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

Condition or disease Intervention/treatment Phase
Suspicion of Being Infected With H.Pylori Device: Modified BreathID Not Applicable

Detailed Description:
The ¹³C-Urea Breath Test (UBT) is a non-invasive test for detecting the presence of Helicobacter pylori (H. pylori) infection by the organism's urease activity. In the presence of H. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13C, results in production of labeled 13CO2, which can be quantified in expired breath. Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water ("13C-urea solution"). Before and after ingestion of the 13C-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. The patient's exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed. The patient is considered H. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (DOB)). The current device marketed by Exalenz is large and costly. Exalenz has built a smaller, cheaper and more reliable new generation device for this application. Equivalence is being demonstrated in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of H.Pylori Infection
Study Start Date : October 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Active Comparator: Clinical Suspicion of Hpylori
All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Device: Modified BreathID
A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula
Other Name: BreathID Hp

Primary Outcome Measures :
  1. Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori [ Time Frame: 25 minutes ]
    The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.

  2. Positive/Negative for H.Pylori With Cleared BreathID [ Time Frame: 1 hour ]
    The amount of subjects that produced positive/negative results with cleared BreathID device

  3. Positive/Negative for H.Pylori With Modified BreathID [ Time Frame: 1 hour ]
    The amount of subjects that produced positive/negative results for H.pylori with modified BreathID

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Be at least 18 years of age
  2. Present with clinical indication of H. pylori
  3. Have the ability and willingness to sign the Informed Consent Form-

Exclusion Criteria:

  1. Current serious disease
  2. Participation in other trials
  3. Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
  4. PPI or H2 blockers for two (2) weeks prior to test
  5. Childbearing or breastfeeding women
  6. Based on opinion of investigator, subject should not be enrolled in this trial
  7. Allergy to citrus juice
  8. Post -eradication therapy for H. pylori

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): NCT01650831

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United States, New Jersey
Unimed Center
East Brunswick, New Jersey, United States, 08816
Sponsors and Collaborators
Exalenz Bioscience LTD.
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Principal Investigator: Jenny Liu, MD Unimed Medical Center
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Responsible Party: Exalenz Bioscience LTD. Identifier: NCT01650831    
Other Study ID Numbers: HP-MBI-0212
First Posted: July 26, 2012    Key Record Dates
Results First Posted: September 2, 2013
Last Update Posted: April 15, 2016
Last Verified: March 2016
Keywords provided by Exalenz Bioscience LTD.:
Helicobacter Pylori
13C Urea Breath Test