GEBT Lot-to-Lot and Biological Variability

Gastroparesis Clinical Trial

Official title:

13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772261
• Other study ID #: PRO-CD-050
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: Cairn Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Diagnostic Test:
• 13C-Spirulina GEBT
Various lots of 13C-Spirulina GEBT test meals

Locations

Country	Name	City	State
United States	Cairn Diagnostics	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cairn Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lot to Lot Variability	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	up to 3 months
Primary	Lot to Lot Variability	Pooled kPCD and standard deviations for each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be calculated and compared for the lot-to-lot comparisons	up to 3 months
Primary	Lot to Lot Variability	Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence	up to 3 months
Primary	Biological Variability	Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other	Up to 3 months
Primary	Biological Variability	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	Up to 3 months