Gastroparesis in Cystic Fibrosis

University of Miami

Status

Withdrawn

Conditions

Gastroparesis

Treatments

Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05223881

20211043

Details and patient eligibility

About

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).

Sex

All

Ages

4+ years old

Volunteers

Accepts Healthy Volunteers

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