PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-06-30

Brief Summary

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This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.

Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.

Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.

Total duration of study is anticipated to be approximately 6 months.

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Detailed Description

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Conditions

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Helicobacter Pylori Safety Efficacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Indication for H. pylori testing

Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison.

Group Type EXPERIMENTAL

PyloPlus Urea Breath Test System

Intervention Type COMBINATION_PRODUCT

System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.

Stool Antigen Test

Intervention Type DIAGNOSTIC_TEST

An antigen test performed via a laboratory to test patients' stool for H. pylori

Interventions

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PyloPlus Urea Breath Test System

System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.

Intervention Type COMBINATION_PRODUCT

Stool Antigen Test

An antigen test performed via a laboratory to test patients' stool for H. pylori

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male or female age 3-17 at the time of visit
* Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
* Naive to H. pylori treatment in the past 4 weeks

Exclusion Criteria

* Pregnant and/or lactating women
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
* Participation in other interventional trials
* Allergy to test substrates
* Antibiotics taken within 4 weeks of the testing
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food
* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes