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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy; Safety; Helicobacter Pylori
• Intervention / Treatment: Combination product: PyloPlus Urea Breath Test System; Diagnostic test: Stool Antigen Test

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trial Manager; Phone Number: 877-855-4100; Email: info@gulfcoastscientific.com

Study Locations

• United States
  • Florida
    • Doral, Florida, United States, 33172
      • Recruiting
      • Dolphin Medical Research
      • Contact: Fermin Nieto; Phone Number: 305-870-5999
      • Principal Investigator: Inosvani Barraso, MD
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health, Inc.
      • Contact: Yazandra Parrimon, RN
      • Principal Investigator: Jeffrey Bornstein, MD
  • Texas
    • El Paso, Texas, United States, 79902
      • Recruiting
      • Harmony United Research
      • Contact: Arthur Imai; Phone Number: 915-519-5297
      • Contact: Miguel Gutierrez; Phone Number: 915-706-9902

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: 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.; Diagnostic test: Stool Antigen Test; An antigen test performed via a laboratory to test patients' stool for H. pylori

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with recorded adverse events	Number of participants with recorded adverse events after performing urea breath test	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Agreement	Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection	7 days

Collaborators and Investigators

• Sponsor: ARJ Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ARJ-2022-PED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes