PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Helicobacter Pylori Infection Clinical Trial

Official title:

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681689
• Other study ID #: ARJ-2022-UBTPT
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2023
• Source: ARJ Medical, Inc.
• Contact: Clinical Trial Manager
• Phone: 877-855-4100
• Email: info[@]gulfcoastscientific.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Helicobacter Pylori Infection

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Dolphin Medical Research	Doral	Florida
United States	Hudson County Clinical Trials Research Center	Union City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
ARJ Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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