PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PyloPlus Urea Breath Test System, Stool Antigen Test.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori, Safety, Efficacy. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Combination product 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. - Diagnostic test Stool Antigen Test
An antigen test performed via a laboratory to test patients' stool for H. pylori
Primary outcome measures
- Number of participants with recorded adverse events [Time frame: 24 hours]
Secondary outcome measures (1)
- Percentage of Agreement [Time frame: 7 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- Dolphin Medical Research — Doral
- Orlando Health, Inc. — Orlando
- Harmony United Research — El Paso
Identifiers
NCT: NCT05276557 · ARJ-2022-PED