GEBT Lot-to-Lot and Biological Variability

NCT04772261 | Completed FDA Device

• 1 other identifier: PRO-CD-050
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

Gastroenterology; Gastric emptying breath test

Outcome Measures

Primary Outcomes (5)

• 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

  up to 3 months

• 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

  up to 3 months

• 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

  up to 3 months

• 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

  Up to 3 months

• 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

  Up to 3 months

Study Arms (2)

Lot-to-Lot Variability

EXPERIMENTAL

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

Diagnostic Test: 13C-Spirulina GEBT

Biological Variability

EXPERIMENTAL

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

Diagnostic Test: 13C-Spirulina GEBT

Interventions

13C-Spirulina GEBT DIAGNOSTIC_TEST

Various lots of 13C-Spirulina GEBT test meals

Biological Variability; Lot-to-Lot Variability

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18-85 years old at time of signing the informed consent form
• Ability to eat test meal and provide breath samples

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairn Diagnostics: lead

Study Sites (1)

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Ryder, MD, PhD

  Cairn Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: February 5, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)