Gastroparesis in Cystic Fibrosis

Study Overview
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Brief Summary
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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).

Official Title
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13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 4 years* and above with a genetically confirmed diagnosis of CF (*This age was chosen as patients younger than 4 years rarely undergo GES) Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic) Exclusion Criteria: History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded. Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease Known hypersensitivity to Spirulina, egg, milk or wheat allergens Patients not able to consume at least 50% of a standard test meal Pregnant women Adults unable to consent Prisoners

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystic Fibrosis<br>Patients who are diagnosed with Cystic Fibrosis. | Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)<br>* 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.<br>|
| Active Comparator: Healthy Normal<br>Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis. | Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Pediatrics, Altered lung function