Status:
WITHDRAWN
Gastroparesis in Cystic Fibrosis
Lead Sponsor:
University of Miami
Conditions:
Gastroparesis
Eligibility:
All Genders
4+ years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05223881
Start Date
February 14 2022
End Date
March 30 2023
Last Update
May 2 2022
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