Testing a new breath test for Helicobacter Pylori in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, non-randomized, open-label study aimed at evaluating the safety and efficacy of the PyloPlus Urea Breath Test System in pediatric patients aged 3 to 17. Participants will undergo testing with non-radioactive 13C-Urea and submit stool samples for analysis. The results from the PyloPlus Analyzer will be kept blinded from the investigators and treating physicians to ensure unbiased patient management decisions. The study is expected to last approximately six months, with subjects enrolled on a walk-in basis.

Why it matters

Who can join: the full rules

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

Where it's running

• Dolphin Medical Research
  Doral, Florida, United States Recruiting
• Orlando Health, Inc.
  Orlando, Florida, United States Recruiting
• Harmony United Research
  El Paso, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Manager
• Email: info@gulfcoastscientific.com
• Phone: 877-855-4100

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.