Gastroparesis
Conditions
Keywords
Gastroenterology, Gastric emptying breath test
Brief summary
The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).
Detailed description
In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% Nitrogen content will be administered. Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling. The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling.
Interventions
DIAGNOSTIC_TESTApproved GEBT test meal
FDA-approve GEBT test meal
Sponsors
Cairn Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 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 syndrome * Symptoms consistent with delayed gastric emptying * 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 * Receipt of an investigational drug within 4 weeks of the study * Pregnancy * Intolerance or allergy to any component of Gastric Emptying Breath Test meal * History of neurologic or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in vivo 13C-Spirulina GEBT response | Up to 2 weeks | Determining the difference between measure gastric emptying rate (kPCD) results produced from the low %N 13C-Spirulina GEBT test meal and the FDA-approved test meal |
Countries
United States
Outcome results
None listed