GastroparesisNCT06004596
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
A study testing 13C-Spirulina Gastric Emptying Breath Test (GEBT) and 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat in people with Gastroparesis, run by Cairn Diagnostics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- 13C-Spirulina Gastric Emptying Breath Test (GEBT) and 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.-
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cairn Diagnostics
Brentwood, Tennessee, 37027
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
Read the 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.
- Conditions
- Gastroparesis
- Being tested
- 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-Spirulina Gastric Emptying Breath Test (GEBT)Diagnostic test
Diagnostic test
13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeatDiagnostic test
Diagnostic test - repeat for biological variability deterination
| Study group | Role | What they receive |
|---|---|---|
| Reference Range determination | Other | 13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants Receives: Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT) |
| Biological Variability | Active comparator | 13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability. Receives: Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT); Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat |
What is being measured
The primary outcome is the main question the study is designed to answer.
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
13CO2 excretion rate calculated at 15 minutes after meal completion
Measured: 15 minutes
kPCD at 30 minutes (min-1)
13CO2 excretion rate calculated at 30 minutes after meal completion
Measured: 30 minutes
kPCD at 45 minutes (min-1)
13CO2 excretion rate calculated at 45 minutes after meal completion
Measured: 45 minutes
kPCD at 60 minutes (min-1)
13CO2 excretion rate calculated at 60 minutes after meal completion
Measured: 60 minutes
kPCD at 90 minutes (min-1)
13CO2 excretion rate calculated at 90 minutes after meal completion
Measured: 90 minutes
kPCD at 120 minutes (min-1)
13CO2 excretion rate calculated at 120 minutes after meal completion
Measured: 120 minutes
kPCD at 150 minutes (min-1)
13CO2 excretion rate calculated at 150 minutes after meal completion
Measured: 150 minutes
kPCD at 180 minutes (min-1)
13CO2 excretion rate calculated at 180 minutes after meal completion
Measured: 180 minutes
kPCD at 210 minutes
13CO2 excretion rate calculated at 210 minutes after meal completion
Measured: 210 minutes
kPCD at 240 minutes (min-1)
13CO2 excretion rate calculated at 240 minutes after meal completion
Measured: 240 minutes
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
Measured: up to 20 minutes
Tmax (mins)
Time of maximum excretion rate - time at which the largest kPCD is observed
Measured: 90 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start17 Mar 2023
- Primary completion31 Jan 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairn Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Catherine E Williams, PhD, Principal investigator, Cairn Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004596
- Sponsor's protocol ID
- CDX-CD-PRO-442
- Status last verified
- Oct 2024
- First submitted
- 1 May 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- ClinicalTrials.gov ID
- NCT06004596
- Acronym / sponsor ID
- CDX-CD-PRO-442
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Cairn DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin, Baylor College of Medicine
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Range determination | Other | Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT)13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants |
| Biological Variability | Active comparator | Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT), Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.-
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-Spirulina Gastric Emptying Breath Test (GEBT)Diagnostic test | Diagnostic test | Biological Variability, Reference Range determination |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeatDiagnostic test - repeat for biological variability deterination | Diagnostic test | Biological Variability |
Primary outcome
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)
Time frame: 15 minutes
13CO2 excretion rate calculated at 15 minutes after meal completion
kPCD at 30 minutes (min-1)
Time frame: 30 minutes
13CO2 excretion rate calculated at 30 minutes after meal completion
kPCD at 45 minutes (min-1)
Time frame: 45 minutes
13CO2 excretion rate calculated at 45 minutes after meal completion
kPCD at 60 minutes (min-1)
Time frame: 60 minutes
13CO2 excretion rate calculated at 60 minutes after meal completion
kPCD at 90 minutes (min-1)
Time frame: 90 minutes
13CO2 excretion rate calculated at 90 minutes after meal completion
kPCD at 120 minutes (min-1)
Time frame: 120 minutes
13CO2 excretion rate calculated at 120 minutes after meal completion
kPCD at 150 minutes (min-1)
Time frame: 150 minutes
13CO2 excretion rate calculated at 150 minutes after meal completion
kPCD at 180 minutes (min-1)
Time frame: 180 minutes
13CO2 excretion rate calculated at 180 minutes after meal completion
kPCD at 210 minutes
Time frame: 210 minutes
13CO2 excretion rate calculated at 210 minutes after meal completion
kPCD at 240 minutes (min-1)
Time frame: 240 minutes
13CO2 excretion rate calculated at 240 minutes after meal completion
Test meal/test completion
Time frame: up to 20 minutes
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 frame: 90 to 240 minutes
Time of maximum excretion rate - time at which the largest kPCD is observed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine E Williams, PhD principal investigator
Cairn Diagnostics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C-Spirulina Gastric Emptying Breath Test (GEBT) and 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat in people with Gastroparesis, run by Cairn Diagnostics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1) (time frame: 15 minutes). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.