Gastroparesis in Cystic Fibrosis

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Gastroparesis
• Intervention / Treatment: Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystic Fibrosis; Patients who are diagnosed with Cystic Fibrosis.	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.
Active Comparator: Healthy Normal; Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of gastric emptying	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.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of gastric emptying over time	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.	6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Daphna Katz, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Anticipated): February 14, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Pediatrics; Altered lung function
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Paralysis; Fibrosis; Cystic Fibrosis; Gastroparesis
• Other Study ID Numbers: 20211043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No