GEBT Lot-to-Lot and Biological Variability

Not Applicable

Completed

• Conditions: Gastroparesis
• Interventions: Diagnostic Test: 13C-Spirulina GEBT

• Registration Number: NCT04772261
• Lead Sponsor: Cairn Diagnostics

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.

Study Timeline

• Study Start: 2021-02-05
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Status Verified: 2022-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lot-to-Lot Variability	13C-Spirulina GEBT	Participants will be administered up to six different 13C-Spirulina test meal lots
Biological Variability	13C-Spirulina GEBT	Participants will be administered the same 13C-Spirulina test meal lot on two different occasions

Primary Outcome Measures

Name	Time	Method
Lot to Lot Variability	up to 3 months	Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence
Biological Variability	Up to 3 months	Pooled, within subject standard deviations of duplicate measurements of kPCD values at each measured timepoint from the same lot of 13C-Spirulina GEBT test meal will be calculated for biological variation using Bartlett's test for homogeneity of variances

Trial Locations

Locations (1)

Cairn Diagnostics; 🇺🇸 Brentwood, Tennessee, United States