GEBT Lot-to-Lot and Biological Variability

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Diagnostic test: 13C-Spirulina GEBT

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Cairn Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lot-to-Lot Variability; Participants will be administered up to six different 13C-Spirulina test meal lots	Diagnostic test: 13C-Spirulina GEBT; Various lots of 13C-Spirulina GEBT test meals
Experimental: Biological Variability; Participants will be administered the same 13C-Spirulina test meal lot on two different occasions	Diagnostic test: 13C-Spirulina GEBT; Various lots of 13C-Spirulina GEBT test meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairn Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Gastroenterology; Gastric emptying breath test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: PRO-CD-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No