NCT05223881

Gastroparesis in Cystic Fibrosis

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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).

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	13^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.

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-09-30
• Completion: 2023-03-30
• First posted: 2022-02-04
• Last updated: 2022-05-02

Regulatory

• FDA-regulated device study