Status:
RECRUITING
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Lead Sponsor:
ARJ Medical, Inc.
Conditions:
Helicobacter Pylori
Safety
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 inclusio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05276557
Start Date
November 17 2022
End Date
June 1 2023
Last Update
May 6 2023
Active Locations (3)
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1
Dolphin Medical Research
Doral, Florida, United States, 33172
2
Orlando Health, Inc.
Orlando, Florida, United States, 32806
3
Harmony United Research
El Paso, Texas, United States, 79902