Gastroparesis in Cystic Fibrosis

NCT05223881 | Withdrawn FDA Device

• 1 other identifier: 20211043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gastroparesis

Keywords

Cystic Fibrosis; Pediatrics; Altered lung function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of gastric emptying over time

  6 months

Study Arms (2)

Cystic Fibrosis

EXPERIMENTAL

Patients who are diagnosed with Cystic Fibrosis.

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

Healthy Normal

ACTIVE COMPARATOR

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)

Interventions

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

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.

Cystic Fibrosis; Healthy Normal

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Gastroparesis; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Daphna Katz, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterology Fellow

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 4, 2022
• Study Start: February 14, 2022
• Primary Completion: September 30, 2022
• Study Completion: March 30, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share