PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Study Overview
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Brief Summary
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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.

Official Title
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PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Conditions
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Helicobacter Pylori Infection, Post-Treatment, Efficacy

Intervention / Treatment
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* Combination Product: PyloPlus UBT System
* Diagnostic Test: Histology
* Diagnostic Test: Rapid Urease Test
* Combination Product: Comparator Breath Test
* Diagnostic Test: Stool Antigen Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indication for H. pylori testing<br>Patients who have been treated for H. pylori and need to undergo eradication confirmation testing. Patients will be enrolled for this study if all acceptance criteria are met. Patients will undergo 13C Urea Breath Test in addition to non-invasive diagnostic comparators (H. pylori Stool Testing and Comparator Breath Test) OR invasive diagnostic comparator (Endoscopy for Rapid Urease Testing and Histology). | Combination Product: PyloPlus UBT System<br>* Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.<br>Diagnostic Test: Histology<br>* Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist.<br>Diagnostic Test: Rapid Urease Test<br>* Biopsy specimen obtained and placed onto Rapid Urease Test<br>Combination Product: Comparator Breath Test<br>* Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.<br>Diagnostic Test: Stool Antigen Test<br>* An antigen test performed via a laboratory to test patient's stool for H. pylori<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Percent Agreement | The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators | 7 days |