Status:
COMPLETED
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Lead Sponsor:
Cairn Diagnostics
Collaborating Sponsors:
Medical College of Wisconsin
Baylor College of Medicine
Conditions:
Gastroparesis
Eligibility:
All Genders
7-18 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are s...
Detailed Description
Children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. Informed consent/assent will be obtained. Breath sampl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06004596
Start Date
March 17 2023
End Date
September 30 2024
Last Update
October 3 2024
Active Locations (3)
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1
Cairn Diagnostics
Brentwood, Tennessee, United States, 37027
2
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226