GEBT Lot-to-Lot and Biological Variability

Cairn Diagnostics21 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroparesis

Interventions

13C-Spirulina GEBTDIAGNOSTIC_TEST

Various lots of 13C-Spirulina GEBT test meals

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cairn Diagnostics

Brentwood, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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