PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

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