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GEBT Lot-to-Lot and Biological Variability | Clinical Trials | Clareo Health

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COMPLETEDNANCT04772261

GEBT Lot-to-Lot and Biological Variability

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.

Lead sponsor: Cairn Diagnostics•1 U.S. locations•View source on ClinicalTrials.gov

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What this study is about

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Sponsors

Lead Sponsor

Cairn Diagnostics

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.

Age

18 - 85 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 18, 2022Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment21

Start dateFeb 2021

Last updatedJan 18, 2022

Condition

Locations shown

Cairn Diagnostics

Brentwood, Tennessee

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2022Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions