GEBT Lot-to-Lot and Biological Variability

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroparesis

Intervention / Treatment
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* Diagnostic Test: 13C-Spirulina GEBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterology, Gastric emptying breath test