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

NCT06004596 | Completed FDA Device

• 1 other identifier: CDX-CD-PRO-442
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Reference Range determination

OTHER

13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants

Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Biological Variability

ACTIVE COMPARATOR

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: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat

Interventions

13C-Spirulina Gastric Emptying Breath Test (GEBT) DIAGNOSTIC_TEST

Diagnostic test

Biological Variability; Reference Range determination

13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat DIAGNOSTIC_TEST

Diagnostic test - repeat for biological variability deterination

Biological Variability

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.-

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairn Diagnostics: lead
• Medical College of Wisconsin: collaborator
• Baylor College of Medicine: collaborator

Study Sites (3)

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

Location

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine E Williams, PhD

  Cairn Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: August 22, 2023
• Study Start: March 17, 2023
• Primary Completion: January 31, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)