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PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
NCT05276557 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Stool Antigen Test
- COMBINATION_PRODUCT PyloPlus Urea Breath Test System
Study Locations (3)
Florida
- Dolphin Medical Research — Doral
- Orlando Health, Inc. — Orlando
Texas
- Harmony United Research — El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2023-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05276557
The ClinicalTrials.gov registry entry for NCT05276557 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ARJ Medical, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Safety appearing as the primary indexed condition, and to 2 interventions — of which Stool Antigen Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05276557 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05276557 about?
NCT05276557 is a clinical study titled "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 e...
What is the current status of trial NCT05276557?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2022-11-17. Estimated completion is 2023-06.
What conditions does trial NCT05276557 study?
This clinical trial studies the following conditions: Safety, Efficacy, Helicobacter Pylori. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05276557?
The interventions under investigation include: Stool Antigen Test (DIAGNOSTIC_TEST), PyloPlus Urea Breath Test System (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05276557?
This trial is sponsored by ARJ Medical, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05276557 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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