Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastroparesis Clinical Trial

Official title:

Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004596
• Other study ID #: CDX-CD-PRO-442
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: Cairn Diagnostics
• Contact: Catherine E Williams, PhD
• Phone: 6153765464
• Email: cwilliams[@]cairndx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally.

Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.

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 samples will be collected by children blowing into test tubes before and after eating a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics.

Researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Diagnostic Test:
• 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Diagnostic test
• 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
Diagnostic test - repeat for biological variability deterination

Locations

Country	Name	City	State
United States	Cairn Diagnostics	Brentwood	Tennessee
United States	Texas Children's Hospital/Baylor College of Medicine	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Cairn Diagnostics	Baylor College of Medicine, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)	13CO2 excretion rate calculated at 15 minutes after meal completion	15 minutes
Primary	kPCD at 30 minutes (min-1)	13CO2 excretion rate calculated at 30 minutes after meal completion	30 minutes
Primary	kPCD at 45 minutes (min-1)	13CO2 excretion rate calculated at 45 minutes after meal completion	45 minutes
Primary	kPCD at 60 minutes (min-1)	13CO2 excretion rate calculated at 60 minutes after meal completion	60 minutes
Primary	kPCD at 90 minutes (min-1)	13CO2 excretion rate calculated at 90 minutes after meal completion	90 minutes
Primary	kPCD at 120 minutes (min-1)	13CO2 excretion rate calculated at 120 minutes after meal completion	120 minutes
Primary	kPCD at 150 minutes (min-1)	13CO2 excretion rate calculated at 150 minutes after meal completion	150 minutes
Primary	kPCD at 180 minutes (min-1)	13CO2 excretion rate calculated at 180 minutes after meal completion	180 minutes
Primary	kPCD at 210 minutes	13CO2 excretion rate calculated at 210 minutes after meal completion	210 minutes
Primary	kPCD at 240 minutes (min-1)	13CO2 excretion rate calculated at 240 minutes after meal completion	240 minutes
Primary	Test meal/test completion	Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed	up to 20 minutes
Primary	Tmax (mins)	Time of maximum excretion rate - time at which the largest kPCD is observed	90 to 240 minutes