Gastroparesis in Cystic Fibrosis

Not Applicable

Withdrawn

• Conditions: Gastroparesis
• Interventions: Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)

• Registration Number: NCT05223881
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Study Start: 2022-02-14
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis	13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)	Patients who are diagnosed with Cystic Fibrosis.
Healthy Normal	13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)	Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.