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Procedure
GEBT Reference Range for Pediatric Gastroparesis
N/A
Waitlist Available
Led By Catherine E Williams, PhD
Research Sponsored by Cairn Diagnostics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation
Be younger than 65 years old
Must not have
Currently receiving prescription drug therapy that may affect gastric motor function or sensation
Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 to 240 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand the normal rate of stomach emptying in children, to aid in diagnosis of gastroparesis.
Who is the study for?
This trial is for healthy children aged 7 to 18 with no significant medical history or developmental delays. They must be able to eat a special test meal and provide breath samples. Children with gastrointestinal, pancreatic, liver diseases, severe respiratory conditions, diabetes, chronic GI symptoms, mental retardation or on drugs affecting stomach function can't participate.
What is being tested?
The trial tests the normal response in kids to the GEBT for diagnosing gastroparesis. It involves eating a Spirulina-enhanced meal and measuring how fast food leaves the stomach by analyzing carbon-13 in their breath before and after eating.
What are the potential side effects?
Since this test involves only eating a meal containing Spirulina and providing breath samples, there are minimal expected side effects. However, participants allergic to ingredients like egg or gluten cannot take part due to potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 7 to 18 years old and both my parents and I agree to participate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on medication that could affect my stomach's movement or feeling.
Select...
I use a daily inhaler for my chronic lung condition.
Select...
I have ongoing stomach or bowel problems.
Select...
I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 to 240 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 to 240 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Test meal/test completion
Tmax (mins)
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reference Range determinationExperimental Treatment1 Intervention
13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants
Group II: Biological VariabilityActive Control2 Interventions
13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
13C-Spirulina Gastric Emptying Breath Test (GEBT)
2023
N/A
~190
Find a Location
Who is running the clinical trial?
Cairn DiagnosticsLead Sponsor
4 Previous Clinical Trials
164 Total Patients Enrolled
4 Trials studying Gastroparesis
164 Patients Enrolled for Gastroparesis
Baylor College of MedicineOTHER
1,028 Previous Clinical Trials
6,029,980 Total Patients Enrolled
6 Trials studying Gastroparesis
733 Patients Enrolled for Gastroparesis
Medical College of WisconsinOTHER
635 Previous Clinical Trials
1,181,520 Total Patients Enrolled
1 Trials studying Gastroparesis
216 Patients Enrolled for Gastroparesis
Catherine E Williams, PhDPrincipal InvestigatorCairn Diagnostics