PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Launched by ARJ MEDICAL, INC. · Mar 3, 2022

Keywords

ClinConnect Summary

The PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study is a clinical trial designed to evaluate a new testing method for detecting Helicobacter pylori (H. pylori) in children. H. pylori is a type of bacteria that can cause stomach problems. This study is open to children aged 3 to 17 who have not received treatment for H. pylori in the last four weeks. Participants will need to provide consent from themselves or their guardians and will take a non-radioactive test that includes a breath sample and a stool sample.

During the trial, children will be tested using the PyloPlus UBT Analyzer, but the results will not be shared with their doctors or used to make treatment decisions. Instead, doctors will order a separate stool test through LabCorp or Quest Diagnostics for diagnosis purposes. The study will take about six months, and it’s important for participants to avoid certain foods and substances before testing. This trial is currently recruiting participants, and it aims to help improve testing methods for H. pylori in children.

Gender

ALL

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