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

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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Helicobacter Pylori Infection
Interventions Device: BreathID® Hp System
Drug: BreathID® Hp Lab System
Diagnostic Test: Stool Test
Enrollment 54
Recruitment Details  
Pre-assignment Details One subject (or parent) signed the consent, but before washout period was completed, decided to withdraw from trial. Therefore, from the 54 consented, only 53 started the study procedure.
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Period Title: Overall Study
Started 53
Completed 41
Not Completed 12
Reason Not Completed
Protocol Violation             11
Device Malfunction             1
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
53
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
30
  56.6%
Male
23
  43.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Hispanic or Latino
4
   7.5%
Not Hispanic or Latino
46
  86.8%
Unknown or Not Reported
3
   5.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
United States 37
Israel 16
1.Primary Outcome
Title Number of Participants With Reported Adverse Events
Hide Description Number of participants with reported adverse events after performing urea breath test
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description:

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.9%
2.Secondary Outcome
Title Percentage of Agreement
Hide Description Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test.
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description:

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of pos. or neg. agreeement
97.56
(87.14 to 99.94)
3.Secondary Outcome
Title Percentage of Agreement
Hide Description Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description:

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of pos. or neg. agreeement
97.62
(87.43 to 99.94)
Time Frame Up to 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indication for Helicobacter Pylori Testing
Hide Arm/Group Description

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.

BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

All-Cause Mortality
Indication for Helicobacter Pylori Testing
Affected / at Risk (%)
Total   0/53 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Indication for Helicobacter Pylori Testing
Affected / at Risk (%) # Events
Total   0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Indication for Helicobacter Pylori Testing
Affected / at Risk (%) # Events
Total   1/53 (1.89%)    
Gastrointestinal disorders   
Vomiting  [1]  1/53 (1.89%)  1
Indicates events were collected by systematic assessment
[1]
Vomiting possibly induced by drinking of test substrate
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator shall be entitled to publish the Proprietary Data in scientific journals and other scientific and professional publications and oral dissertations and the like, provided that a draft of the intended publication or dissertation shall be submitted to the Company at least sixty (60) days before the date of intended publication or dissertation so as to enable the Company to make comments to the Center regarding the contents of such intended publication or dissertation.
Results Point of Contact
Name/Title: Avraham Hershkowitz
Organization: Exalenz Bisocience
Phone: 972-8-9737513
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02905825     History of Changes
Other Study ID Numbers: PED-HP-0616B
First Submitted: September 6, 2016
First Posted: September 19, 2016
Results First Submitted: March 25, 2018
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018