Gastroparesis in Cystic Fibrosis (NCT05223881) | Clinical Trial Compass
WithdrawnNot Applicable
Gastroparesis in Cystic Fibrosis
Stopped: Study is not feasible at this time due to staffing limitations
0Started 2022-02-14
Plain-language 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).
Who can participate
Age range4 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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