Trial Outcomes & Findings for Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics (NCT NCT02905825)

NCT ID: NCT02905825

Last Updated: 2022-12-20

Results Overview

Number of participants with reported adverse events after performing urea breath test

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 54 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2022-12-20

Participant Flow

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.

Participant milestones

Measure	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. 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 Study STARTED	53
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	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. 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 Study Protocol Violation	11
Overall Study Device Malfunction	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Indication for Helicobacter Pylori Testing n=53 Participants 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
Age, Categorical <=18 years	53 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants
Region of Enrollment Israel	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Number of participants with reported adverse events after performing urea breath test

Outcome measures

Measure

Indication for Helicobacter Pylori Testing n=53 Participants 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

Number of Participants With Reported Adverse Events

1 Participants

SECONDARY outcome

Timeframe: 1 week

Population: Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test.

Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection

Outcome measures

Measure

Indication for Helicobacter Pylori Testing n=41 Participants 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

Percentage of Agreement

97.56 percentage of pos. or neg. agreeement Interval 87.14 to 99.94

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Indication for Helicobacter Pylori Testing n=42 Participants 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

Percentage of Agreement

97.62 percentage of pos. or neg. agreeement Interval 87.43 to 99.94

Adverse Events

Indication for Helicobacter Pylori Testing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Indication for Helicobacter Pylori Testing n=53 participants at risk 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

Gastrointestinal disorders Vomiting

1.9% 1/53 • Number of events 1 • Up to 6 weeks

Additional Information

Avraham Hershkowitz

Exalenz Bisocience

Phone: 972-8-9737513

Email: avrahamh@exalenz.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER