Helicobacter Pylori Infection, Post-Treatment, Efficacy
Conditions
Brief summary
This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) 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 either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.
Interventions
COMBINATION_PRODUCTPyloPlus UBT System
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
DIAGNOSTIC_TESTHistology
Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist.
DIAGNOSTIC_TESTRapid Urease Test
Biopsy specimen obtained and placed onto Rapid Urease Test
COMBINATION_PRODUCTComparator Breath Test
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
DIAGNOSTIC_TESTStool Antigen Test
An antigen test performed via a laboratory to test patient's stool for H. pylori
Sponsors
ARJ Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Percent Agreement | 7 days | The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators |
Countries
United States
Contacts
Primary ContactClinical Trial Manager
Outcome results
None listed