GEBT Lot-to-Lot and Biological Variability

• Sponsor: Cairn Diagnostics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04772261
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Diagnostic Test: 13C-Spirulina GEBT	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
• Actual Study Start Date: Feb 5, 2021
• Actual Primary Completion Date: Jan 10, 2022
• Actual Study Completion Date: Jan 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lot to Lot Variability [up to 3 months]

   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

2. Lot to Lot Variability [up to 3 months]

   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

3. Lot to Lot Variability [up to 3 months]

   Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence

4. Biological Variability [Up to 3 months]

   Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other

5. Biological Variability [Up to 3 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairn Diagnostics	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

• Cairn Diagnostics

Investigators

• Principal Investigator: Alex Ryder, MD, PhD, Cairn Diagnostics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 1, 2021

More Information

Publications

None provided.

• Responsible Party: Cairn Diagnostics
• ClinicalTrials.gov Identifier: NCT04772261
• Other Study ID Numbers: PRO-CD-050
• First Posted: Feb 26, 2021
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Cairn Diagnostics: Gastroenterology; Gastric emptying breath test
• Additional relevant MeSH terms: Gastroparesis

Study Results

No Results Posted as of Jan 18, 2022