Gastroparesis in Cystic Fibrosis

Sponsor
University of Miami (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05223881
Collaborator
(none)
0
2
13.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
Anticipated Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daphna Katz, Pediatric Gastroenterology Fellow, University of Miami
ClinicalTrials.gov Identifier:
NCT05223881
Other Study ID Numbers:
  • 20211043
First Posted:
Feb 4, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Daphna Katz, Pediatric Gastroenterology Fellow, University of Miami
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022