Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT05276557
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT05276557
Study Brief:
Protocol Section:
NCT05276557