NCT06004596

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

Cairn Diagnostics·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
13C-Spirulina Gastric Emptying Breath Test (GEBT)
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Cairn Diagnostics
Location
Brentwood,Houston,Milwaukee, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 17, 2023
End date
Oct 31, 2024
Enrollment
300 participants
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
Attention to gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06004596
Type
Non-Device Trial
About this record

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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