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Completed

NCT Number: NCT04772261

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13C-Spirulina GEBT

Diagnostic Test

Various lots of 13C-Spirulina GEBT test meals

Primary outcomes

  1. Lot to Lot Variability

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairn Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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