Testing a new breath test for Helicobacter Pylori in children
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
This study is testing a new breath test to see if it can safely and effectively detect Helicobacter Pylori in children aged 3 to 17.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | ARJ Medical, Inc. Industry-sponsored |
| Locations | 3 sites (Doral, Florida and 2 other locations) |
| Trial ID | NCT05276557 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, non-randomized, open-label study aimed at evaluating the safety and efficacy of the PyloPlus Urea Breath Test System in pediatric patients aged 3 to 17. Participants will undergo testing with non-radioactive 13C-Urea and submit stool samples for analysis. The results from the PyloPlus Analyzer will be kept blinded from the investigators and treating physicians to ensure unbiased patient management decisions. The study is expected to last approximately six months, with subjects enrolled on a walk-in basis.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 17 who have not received H. Pylori treatment in the past four weeks.
Not a fit: Patients who are pregnant, lactating, or have certain medical conditions that could compromise their safety or data quality will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for diagnosing Helicobacter Pylori in children.
How similar studies have performed: Other studies have shown success with breath tests for H. Pylori, but the specific use of the PyloPlus UBT System in this population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Doral, Florida and 2 other locations
- Dolphin Medical Research — Doral, Florida, United States (Recruiting)
- Orlando Health, Inc. — Orlando, Florida, United States (Recruiting)
- Harmony United Research — El Paso, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Manager
- Email: info@gulfcoastscientific.com
- Phone: 877-855-4100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.