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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05276557
Study type Interventional
Source ARJ Medical, Inc.
Contact Clinical Trial Manager
Phone 877-855-4100
Email info@gulfcoastscientific.com
Status Recruiting
Phase Phase 3
Start date November 17, 2022
Completion date June 2023

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