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

NCT06004596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-10-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Cairn Diagnostics

    lead INDUSTRY

Principal Investigators

  • Catherine E Williams, PhD · Cairn Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2024-01-31
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004596 on ClinicalTrials.gov