Gastroparesis
Conditions
Keywords
Gastroenterology, Gastric emptying breath test
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 second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.
Interventions
DIAGNOSTIC_TEST13C-Spirulina GEBT
Various lots of 13C-Spirulina GEBT test meals
Sponsors
Cairn Diagnostics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lot to Lot Variability | up to 3 months | Participant kPCD values at each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be plotted to compare in vivo results across each lot of material |
| Biological Variability | Up to 3 months | Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other |
Countries
United States
Outcome results
None listed