PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Description

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

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Study Overview

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Study Details

Study overview

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.

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Condition
Helicobacter Pylori
Intervention / Treatment

-

Contacts and Locations

Doral

Dolphin Medical Research, Doral, Florida, United States, 33172

Orlando

Orlando Health, Inc., Orlando, Florida, United States, 32806

El Paso

Harmony United Research, El Paso, Texas, United States, 79902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

3 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ARJ Medical, Inc.,

Study Record Dates

2023-06