GEBT Lot-to-Lot and Biological Variability

Cairn Diagnostics

Status

Completed

Conditions

Gastroparesis

Treatments

Diagnostic Test: 13C-Spirulina GEBT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04772261

PRO-CD-050

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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