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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
| Baylor College of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Range determination | Other | 13C-Spirulina Gastric Emptying Breath Test (GEBT) administered to healthy participants |
|
| Biological Variability | Active Comparator | 13C-Spirulina GEBT administered a second time to subset of participants to determine pediatric biological variability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) | Diagnostic Test | Diagnostic test |
|
| Measure | Description | Time Frame |
|---|---|---|
| kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1) | 13CO2 excretion rate calculated at 15 minutes after meal completion | 15 minutes |
| kPCD at 30 minutes (min-1) | 13CO2 excretion rate calculated at 30 minutes after meal completion | 30 minutes |
| kPCD at 45 minutes (min-1) | 13CO2 excretion rate calculated at 45 minutes after meal completion | 45 minutes |
| kPCD at 60 minutes (min-1) | 13CO2 excretion rate calculated at 60 minutes after meal completion | 60 minutes |
| kPCD at 90 minutes (min-1) | 13CO2 excretion rate calculated at 90 minutes after meal completion | 90 minutes |
| kPCD at 120 minutes (min-1) | 13CO2 excretion rate calculated at 120 minutes after meal completion | 120 minutes |
| kPCD at 150 minutes (min-1) | 13CO2 excretion rate calculated at 150 minutes after meal completion | 150 minutes |
| kPCD at 180 minutes (min-1) | 13CO2 excretion rate calculated at 180 minutes after meal completion |
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Inclusion Criteria:
Exclusion Criteria:
Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease
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| Name | Affiliation | Role |
|---|---|---|
| Catherine E Williams, PhD | Cairn Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairn Diagnostics | Brentwood | Tennessee | 37027 | United States | ||
| Texas Children's Hospital/Baylor College of Medicine |
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| 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat | Diagnostic Test | Diagnostic test - repeat for biological variability deterination |
|
| 180 minutes |
| kPCD at 210 minutes | 13CO2 excretion rate calculated at 210 minutes after meal completion | 210 minutes |
| kPCD at 240 minutes (min-1) | 13CO2 excretion rate calculated at 240 minutes after meal completion | 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 | up to 20 minutes |
| Tmax (mins) | Time of maximum excretion rate - time at which the largest kPCD is observed | 90 to 240 minutes |
| Houston |
| Texas |
| 77030 |
| United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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