NCT06004596

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Cairn Diagnostics · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	13C-Spirulina Gastric Emptying Breath Test (GEBT)	Diagnostic test
DIAGNOSTIC_TEST	13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat	Diagnostic test - repeat for biological variability deterination

Timeline

• Start date: 2023-03-17
• Primary completion: 2024-01-31
• Completion: 2024-09-30
• First posted: 2023-08-22
• Last updated: 2024-10-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study