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GEBT Lot-to-Lot and Biological Variability

Primary Purpose

Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
13C-Spirulina GEBT
Sponsored by
Cairn Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis focused on measuring Gastroenterology, Gastric emptying breath test

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairn Diagnostics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lot-to-Lot Variability

Biological Variability

Arm Description

Participants will be administered up to six different 13C-Spirulina test meal lots

Participants will be administered the same 13C-Spirulina test meal lot on two different occasions

Outcomes

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
January 14, 2022
Sponsor
Cairn Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT04772261
Brief Title
GEBT Lot-to-Lot and Biological Variability
Official Title
13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cairn Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroenterology, Gastric emptying breath test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lot-to-Lot Variability
Arm Type
Experimental
Arm Description
Participants will be administered up to six different 13C-Spirulina test meal lots
Arm Title
Biological Variability
Arm Type
Experimental
Arm Description
Participants will be administered the same 13C-Spirulina test meal lot on two different occasions
Intervention Type
Diagnostic Test
Intervention Name(s)
13C-Spirulina GEBT
Intervention Description
Various lots of 13C-Spirulina GEBT test meals
Primary Outcome Measure Information:
Title
Lot to Lot Variability
Description
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
Title
Lot to Lot Variability
Description
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
Title
Lot to Lot Variability
Description
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
Title
Biological Variability
Description
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
Title
Biological Variability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Ryder, MD, PhD
Organizational Affiliation
Cairn Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairn Diagnostics
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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GEBT Lot-to-Lot and Biological Variability

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