Gastroparesis in Cystic Fibrosis

NCT ID: NCT05223881

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2023-03-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cystic Fibrosis

Patients who are diagnosed with Cystic Fibrosis.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Healthy Normal

Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Daphna Katz

Pediatric Gastroenterology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daphna Katz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Other Identifiers

20211043

Identifier Type: -

Identifier Source: org_study_id