Recruiting
Phase 3

PyloPlus

Sponsor:

ARJ Medical, Inc.

Code:

NCT05276557

Conditions

Helicobacter Pylori

Safety

Efficacy

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

PyloPlus Urea Breath Test System

Stool Antigen Test

Study Details

Brief summary:

This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.

Centers 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 prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.

Total duration of study is anticipated to be approximately 6 months.

Conditions

Helicobacter Pylori

Safety

Efficacy

Study ID

NCT05276557

Start date

Nov 17, 2022

Status verified date

May, 2023

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or female age 3-17 at the time of visit
  • Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
  • Naive to H. pylori treatment in the past 4 weeks

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 of the quality of 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
  • Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Indication for H. pylori testing

Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison.

Interventions

PyloPlus Urea Breath Test System

System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.

Stool Antigen Test

An antigen test performed via a laboratory to test patients' stool for H. pylori

Primary outcome measure

  • Number of participants with recorded adverse events [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager

877-855-4100info@gulfcoastscientific.com

Locations

Dolphin Medical Research

Recruiting

Doral, Florida, United States, 33172

Contacts

Fermin Nieto

305-870-5999

Principal Investigator:

Inosvani Barraso, MD

Orlando Health, Inc.

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Jeffrey Bornstein, MD

Harmony United Research

Recruiting

El Paso, Texas, United States, 79902

Contacts

Arthur Imai

915-519-5297

Miguel Gutierrez

915-706-9902

Principal Investigator:

Aldo Maspons, MD

More Information

Sponsor

ARJ Medical, Inc.

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ARJ Medical, Inc. on 2023-05-06.