Status:
COMPLETED
GEBT Lot-to-Lot and Biological Variability
Lead Sponsor:
Cairn Diagnostics
Conditions:
Gastroparesis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.
Detailed Description
In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the ...
Eligibility Criteria
Inclusion
- Males and females, 18-85 years old at time of signing the informed consent form
- Ability to eat test meal and provide breath samples
Exclusion
- History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
- History of abdominal surgery except appendectomy
- Use of any medications that may alter gastric motility within two days of the study
- Use of narcotics or anticholinergics within two days of the study
- Females on hormone replacement therapy other than birth control medications
- Pregnancy
- Intolerance or allergy to any component of GEBT test meal
- History of neurologic or psychiatric disorders
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04772261
Start Date
February 5 2021
End Date
January 10 2022
Last Update
January 18 2022
Active Locations (1)
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1
Cairn Diagnostics
Brentwood, Tennessee, United States, 37027