PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Helicobacter Pylori Infection 🦠 Post-Treatment 🦠 Efficacy

🗓️ Study Start (Actual) 21 December 2022

🗓️ Primary Completion (Estimated) June 2023

✅ Study Completion (Estimated) June 2023

👥 Enrollment (Estimated) 77

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Doral, Florida, United States

📍 Union City, New Jersey, United States

📋 Eligibility Criteria

Description

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: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 28 December 2022
First Submitted that Met QC Criteria 28 December 2022
First Posted 12 January 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 3 May 2023
Last Update Posted 6 May 2023
Last Verified May 2023