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Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Primary Purpose

Gastroparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
13C-Spirulina Gastric Emptying Breath Test (GEBT)
13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
Sponsored by
Cairn Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation Healthy and without any significant prior medical history or developmental delays Able to eat the test meal and provide breath samples.- Exclusion Criteria: Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler Type 1 or 2 Diabetes Chronic gastrointestinal symptoms or functional gastrointestinal disorders Mental retardation or pervasive developmental disorder Currently receiving prescription drug therapy that may affect gastric motor function or sensation Any over-the-counter or herbal supplements that may affect gastric motor function or sensation Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal

Sites / Locations

  • Cairn Diagnostics
  • Texas Children's Hospital/Baylor College of MedicineRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Reference Range determination

Biological Variability

Arm Description

13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants

13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.

Outcomes

Primary Outcome Measures

kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
13CO2 excretion rate calculated at 15 minutes after meal completion
kPCD at 30 minutes (min-1)
13CO2 excretion rate calculated at 30 minutes after meal completion
kPCD at 45 minutes (min-1)
13CO2 excretion rate calculated at 45 minutes after meal completion
kPCD at 60 minutes (min-1)
13CO2 excretion rate calculated at 60 minutes after meal completion
kPCD at 90 minutes (min-1)
13CO2 excretion rate calculated at 90 minutes after meal completion
kPCD at 120 minutes (min-1)
13CO2 excretion rate calculated at 120 minutes after meal completion
kPCD at 150 minutes (min-1)
13CO2 excretion rate calculated at 150 minutes after meal completion
kPCD at 180 minutes (min-1)
13CO2 excretion rate calculated at 180 minutes after meal completion
kPCD at 210 minutes
13CO2 excretion rate calculated at 210 minutes after meal completion
kPCD at 240 minutes (min-1)
13CO2 excretion rate calculated at 240 minutes after meal completion
Test meal/test completion
Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed
Tmax (mins)
Time of maximum excretion rate - time at which the largest kPCD is observed

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
August 21, 2023
Sponsor
Cairn Diagnostics
Collaborators
Medical College of Wisconsin, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT06004596
Brief Title
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Official Title
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cairn Diagnostics
Collaborators
Medical College of Wisconsin, Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally. Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.
Detailed Description
Children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. Informed consent/assent will be obtained. Breath samples will be collected by children blowing into test tubes before and after eating a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics. Researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reference Range determination
Arm Type
Other
Arm Description
13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants
Arm Title
Biological Variability
Arm Type
Active Comparator
Arm Description
13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability.
Intervention Type
Diagnostic Test
Intervention Name(s)
13C-Spirulina Gastric Emptying Breath Test (GEBT)
Intervention Description
Diagnostic test
Intervention Type
Diagnostic Test
Intervention Name(s)
13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
Intervention Description
Diagnostic test - repeat for biological variability deterination
Primary Outcome Measure Information:
Title
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
Description
13CO2 excretion rate calculated at 15 minutes after meal completion
Time Frame
15 minutes
Title
kPCD at 30 minutes (min-1)
Description
13CO2 excretion rate calculated at 30 minutes after meal completion
Time Frame
30 minutes
Title
kPCD at 45 minutes (min-1)
Description
13CO2 excretion rate calculated at 45 minutes after meal completion
Time Frame
45 minutes
Title
kPCD at 60 minutes (min-1)
Description
13CO2 excretion rate calculated at 60 minutes after meal completion
Time Frame
60 minutes
Title
kPCD at 90 minutes (min-1)
Description
13CO2 excretion rate calculated at 90 minutes after meal completion
Time Frame
90 minutes
Title
kPCD at 120 minutes (min-1)
Description
13CO2 excretion rate calculated at 120 minutes after meal completion
Time Frame
120 minutes
Title
kPCD at 150 minutes (min-1)
Description
13CO2 excretion rate calculated at 150 minutes after meal completion
Time Frame
150 minutes
Title
kPCD at 180 minutes (min-1)
Description
13CO2 excretion rate calculated at 180 minutes after meal completion
Time Frame
180 minutes
Title
kPCD at 210 minutes
Description
13CO2 excretion rate calculated at 210 minutes after meal completion
Time Frame
210 minutes
Title
kPCD at 240 minutes (min-1)
Description
13CO2 excretion rate calculated at 240 minutes after meal completion
Time Frame
240 minutes
Title
Test meal/test completion
Description
Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed
Time Frame
up to 20 minutes
Title
Tmax (mins)
Description
Time of maximum excretion rate - time at which the largest kPCD is observed
Time Frame
90 to 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation Healthy and without any significant prior medical history or developmental delays Able to eat the test meal and provide breath samples.- Exclusion Criteria: Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler Type 1 or 2 Diabetes Chronic gastrointestinal symptoms or functional gastrointestinal disorders Mental retardation or pervasive developmental disorder Currently receiving prescription drug therapy that may affect gastric motor function or sensation Any over-the-counter or herbal supplements that may affect gastric motor function or sensation Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine E Williams, PhD
Phone
6153765464
Ext
103
Email
cwilliams@cairndx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan McClain, PhD
Phone
6153765464
Ext
105
Email
emcclain@cairndx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine E Williams, PhD
Organizational Affiliation
Cairn Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairn Diagnostics
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Children's Hospital/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Charron
Phone
713-798-0381
Email
heather.charron@bcm.edu
First Name & Middle Initial & Last Name & Degree
Bruno Chumpitazi, MD
Phone
8328223616
Email
chumpita@bcm.edu
First Name & Middle Initial & Last Name & Degree
Bruno Chumpitazi, MD MPH
First Name & Middle Initial & Last Name & Degree
Robert J Shulman, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Grimm
Phone
414-266-6111
Email
mgrimm@mcw.edu
First Name & Middle Initial & Last Name & Degree
katja kovacic, MD
Phone
4162663690
Email
kkovacic@mcw.edu
First Name & Middle Initial & Last Name & Degree
Katja Kovacic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

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