PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2022
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedStudy Start
First participant enrolled
November 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 6, 2023
May 1, 2023
7 months
March 3, 2022
May 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with recorded adverse events
Number of participants with recorded adverse events after performing urea breath test
24 hours
Secondary Outcomes (1)
Percentage of Agreement
7 days
Study Arms (1)
Indication for H. pylori testing
EXPERIMENTALWalk 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
System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.
An antigen test performed via a laboratory to test patients' stool for H. pylori
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dolphin Medical Research
Doral, Florida, 33172, United States
Orlando Health, Inc.
Orlando, Florida, 32806, United States
Harmony United Research
El Paso, Texas, 79902, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
March 11, 2022
Study Start
November 17, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
May 6, 2023
Record last verified: 2023-05