Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Trial NCT06004596
Access comprehensive clinical trial information for NCT06004596 through Pure Global AI's free database. This phase not specified trial is sponsored by Cairn Diagnostics and is currently Recruiting. The study focuses on Gastroparesis. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Cairn Diagnostics
Timeline & Enrollment
N/A
Mar 17, 2023
Oct 31, 2024
Primary Outcome
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1),kPCD at 30 minutes (min-1),kPCD at 45 minutes (min-1),kPCD at 60 minutes (min-1),kPCD at 90 minutes (min-1),kPCD at 120 minutes (min-1),kPCD at 150 minutes (min-1),kPCD at 180 minutes (min-1),kPCD at 210 minutes,kPCD at 240 minutes (min-1),Test meal/test completion,Tmax (mins)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06004596
Non-Device Trial