Gastroparesis
Conditions
Keywords
Cystic Fibrosis, Pediatrics, Altered lung function
Brief summary
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).
Interventions
DEVICE13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
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.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of gastric emptying | 4 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of gastric emptying over time | 6 months | 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. |
Outcome results
None listed