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NCT Number: NCT05276557

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

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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Key information

Conditions

Helicobacter Pylori Efficacy Safety

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dolphin Medical Research, Doral, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PyloPlus Urea Breath Test System

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

Diagnostic Test

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

Primary outcomes

  1. Number of participants with recorded adverse events

    Time frame: 24 hours

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

Secondary outcomes

  1. Percentage of Agreement

    Time frame: 7 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Manager

CONTACT

[email protected]

877-855-4100

Sponsors and collaborators

Lead sponsor

ARJ Medical, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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