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Study is not feasible at this time due to staffing limitations
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The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystic Fibrosis | Experimental | Patients who are diagnosed with Cystic Fibrosis. |
|
| Healthy Normal | Active Comparator | Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) | Device | After an overnight (minimum 8 hours) fast, patients are given a standardized test meal, after which they are administered the GEBT. Patients are asked to hold a glass tube in a comfortable position, take a deep breath and pause momentarily, blow gently into the tube for 5 - 10 seconds, slowly withdraw straw from tube while continuing to breath into tube, and immediately close the tube securely with the cap. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of gastric emptying | The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of gastric emptying over time | The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daphna Katz, MD | University of Miami | Principal Investigator |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |