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RecruitingAccepts healthy volunteersPhase 3

PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

ARJ Medical, Inc. · NCT05276557

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–17 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
40
US sites recruiting
3
Study start
November 17, 2022
Record last updated
May 6, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PyloPlus Urea Breath Test System; Stool Antigen Test

Conditions: Helicobacter Pylori; Safety; Efficacy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Dolphin Medical Research

    Doral, FL 33172

    Site contact: Fermin Nieto · 305-870-5999

  • Orlando Health, Inc.

    Orlando, FL 32806

    Site contact: Yazandra Parrimon, RN

  • Harmony United Research

    El Paso, TX 79902

    Site contact: Arthur Imai · 915-519-5297

Study contacts (from the official record)

  • Clinical Trial Manager · 877-855-4100 · info@gulfcoastscientific.com
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PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study (NCT05276557) | Bored Studies