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Clinical Trials in the USA / NCT05276557
Recruiting Phase 3

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

NCT05276557 · tracked via the Priya Life Science USA tracker
Sponsor
ARJ Medical, Inc
Phase
Phase 3
Started
2022-11-17
Last updated
2023-05-06

Condition(s) studied

Helicobacter PyloriSafetyEfficacy

Investigational drug(s) / intervention(s)

PyloPlus Urea Breath Test SystemStool Antigen Test

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.

Stool Antigen Test: An antigen test performed via a laboratory to test patients' stool for H. pylori

Study summary

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Number of participants with recorded adverse events — 24 hours
    Number of participants with recorded adverse events after performing urea breath test

Trial sites (3)

FacilityCityRegionStatus
Dolphin Medical Research Doral Florida Recruiting
Orlando Health, Inc. Orlando Florida Recruiting
Harmony United Research El Paso Texas Recruiting

More ARJ Medical, Inc. trials in the USA

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study Recruiting

Other trials for the same condition

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination Recruiting
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05276557 on ClinicalTrials.gov ↗ ← All trials in the USA