Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Gastroparesis
About this trial
This is an interventional diagnostic trial for Gastroparesis
Eligibility Criteria
Inclusion Criteria: Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation Healthy and without any significant prior medical history or developmental delays Able to eat the test meal and provide breath samples.- Exclusion Criteria: Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler Type 1 or 2 Diabetes Chronic gastrointestinal symptoms or functional gastrointestinal disorders Mental retardation or pervasive developmental disorder Currently receiving prescription drug therapy that may affect gastric motor function or sensation Any over-the-counter or herbal supplements that may affect gastric motor function or sensation Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal
Sites / Locations
- Cairn Diagnostics
- Texas Children's Hospital/Baylor College of MedicineRecruiting
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Active Comparator
Reference Range determination
Biological Variability
13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants
13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.