Testing the effectiveness of the PyloPlus Urea Breath Test for H. pylori after treatment
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
This study is testing if the PyloPlus Urea Breath Test can accurately confirm that people who have been treated for H. pylori no longer have the infection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ARJ Medical, Inc. Industry-sponsored |
| Locations | 2 sites (Doral, Florida and 1 other locations) |
| Trial ID | NCT05681689 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, non-randomized, open-label study designed to evaluate the efficacy of the PyloPlus Urea Breath Test (UBT) system in confirming the eradication of Helicobacter pylori infection after treatment. Eligible participants, who have been treated for H. pylori within the past six months, will undergo testing using non-radioactive 13C-Urea and may provide stool samples or undergo endoscopy for additional testing. The results from the PyloPlus UBT will be compared against established methods such as the H. pylori Stool Antigen Test and Rapid Urease Test to assess its accuracy and reliability.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with H. pylori and treated within the last six months.
Not a fit: Patients who are pregnant, lactating, or have certain medical conditions that could compromise safety or data quality will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and non-invasive method for confirming the eradication of H. pylori infections in patients.
How similar studies have performed: Previous studies have shown success with breath tests for H. pylori, but the PyloPlus UBT system is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female at least 18 years of age * Patients who have been diagnosed with H. pylori and have been treated within the past 6 months * Naive to H. pylori treatment in the past 4 weeks (including PPIs) 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 or the quality of the 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
Where this trial is running
Doral, Florida and 1 other locations
- Dolphin Medical Research — Doral, Florida, United States (Recruiting)
- Hudson County Clinical Trials Research Center — Union City, New Jersey, 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.