PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PyloPlus UBT System, Histology, Rapid Urease Test, Comparator Breath Test.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection, Post-Treatment, Efficacy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 product PyloPlus UBT System
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. - Diagnostic test Histology
Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist. - Diagnostic test Rapid Urease Test
Biopsy specimen obtained and placed onto Rapid Urease Test - Combination product Comparator Breath Test
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. - Diagnostic test Stool Antigen Test
An antigen test performed via a laboratory to test patient's stool for H. pylori
Primary outcome measures
- Overall Percent Agreement [Time frame: 7 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Dolphin Medical Research — Doral
- Hudson County Clinical Trials Research Center — Union City
Identifiers
NCT: NCT05681689 · ARJ-2022-UBTPT