GEBT Lot-to-Lot and Biological Variability

NCT ID: NCT04772261

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2022-01-10

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.

Conditions

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Gastroparesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lot-to-Lot Variability

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

Group Type EXPERIMENTAL

13C-Spirulina GEBT

Intervention Type DIAGNOSTIC_TEST

Various lots of 13C-Spirulina GEBT test meals

Biological Variability

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

Group Type EXPERIMENTAL

13C-Spirulina GEBT

Intervention Type DIAGNOSTIC_TEST

Various lots of 13C-Spirulina GEBT test meals

Interventions

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13C-Spirulina GEBT

Various lots of 13C-Spirulina GEBT test meals

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairn Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Ryder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairn Diagnostics

Locations

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Cairn Diagnostics

Brentwood, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO-CD-050

Identifier Type: -

Identifier Source: org_study_id

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