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

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.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Diagnostic test: 13C-Spirulina Gastric Emptying Breath Test (GEBT); Diagnostic test: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Cairn Diagnostics
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital/Baylor College of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reference Range determination; 13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants	Diagnostic test: 13C-Spirulina Gastric Emptying Breath Test (GEBT); Diagnostic test
Active Comparator: Biological Variability; 13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
kPCD at 30 minutes (min-1)	13CO2 excretion rate calculated at 30 minutes after meal completion	30 minutes
kPCD at 45 minutes (min-1)	13CO2 excretion rate calculated at 45 minutes after meal completion	45 minutes
kPCD at 60 minutes (min-1)	13CO2 excretion rate calculated at 60 minutes after meal completion	60 minutes
kPCD at 90 minutes (min-1)	13CO2 excretion rate calculated at 90 minutes after meal completion	90 minutes
kPCD at 120 minutes (min-1)	13CO2 excretion rate calculated at 120 minutes after meal completion	120 minutes
kPCD at 150 minutes (min-1)	13CO2 excretion rate calculated at 150 minutes after meal completion	150 minutes
kPCD at 180 minutes (min-1)	13CO2 excretion rate calculated at 180 minutes after meal completion	180 minutes
kPCD at 210 minutes	13CO2 excretion rate calculated at 210 minutes after meal completion	210 minutes
kPCD at 240 minutes (min-1)	13CO2 excretion rate calculated at 240 minutes after meal completion	240 minutes
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
Tmax (mins)	Time of maximum excretion rate - time at which the largest kPCD is observed	90 to 240 minutes

Collaborators and Investigators

• Sponsor: Cairn Diagnostics
• Collaborators: Baylor College of Medicine; Medical College of Wisconsin
• Investigators: Principal Investigator: Catherine E Williams, PhD, Cairn Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: CDX-CD-PRO-442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No