Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

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.
 
ClinicalTrials.gov Identifier: NCT02905825
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Tracking Information
First Submitted Date  ICMJE September 6, 2016
First Posted Date  ICMJE September 19, 2016
Results First Submitted Date  ICMJE March 25, 2018
Results First Posted Date  ICMJE July 4, 2018
Last Update Posted Date July 4, 2018
Actual Study Start Date  ICMJE May 18, 2017
Actual Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Number of Participants With Reported Adverse Events [ Time Frame: 24 hours ]
Number of participants with reported adverse events after performing urea breath test
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02905825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Percentage of Agreement [ Time Frame: 1 week ]
    Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
  • Percentage of Agreement [ Time Frame: 1 week ]
    Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Official Title  ICMJE Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Brief Summary Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Detailed Description Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)
Masking Description:
The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Primary Purpose: Diagnostic
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Device: BreathID® Hp System
    Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
  • Drug: BreathID® Hp Lab System
    Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
  • Diagnostic Test: Stool Test
    Each subject was asked to perform a stool test in parallel to the breath test.
    Other Name: Stool Antigen Test
Study Arms  ICMJE Experimental: Indication for Helicobacter pylori testing
Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.
Interventions:
  • Device: BreathID® Hp System
  • Drug: BreathID® Hp Lab System
  • Diagnostic Test: Stool Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
54
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 5, 2017
Actual Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be older than 3 and younger than 18 years of age
  • Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
  • Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
  • Naïve to H. pylori treatment in the past 6 weeks

Exclusion Criteria:

  • Participation in other interventional trials
  • PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
  • Pregnant or breastfeeding female
  • Allergy to test substrates
  • Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
  • Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
  • Exposure to any 13C-enriched substance 24 hours prior to the breath test.
  • Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
  • Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905825
Other Study ID Numbers  ICMJE PED-HP-0616B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Exalenz Bioscience LTD.
Study Sponsor  ICMJE Exalenz Bioscience LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Exalenz Bioscience LTD.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP