search
Back to results

Gastroparesis in Cystic Fibrosis

Primary Purpose

Gastroparesis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis focused on measuring Cystic Fibrosis, Pediatrics, Altered lung function

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cystic Fibrosis

    Healthy Normal

    Arm Description

    Patients who are diagnosed with Cystic Fibrosis.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    April 26, 2022
    Sponsor
    University of Miami
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05223881
    Brief Title
    Gastroparesis in Cystic Fibrosis
    Official Title
    13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study is not feasible at this time due to staffing limitations
    Study Start Date
    February 14, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    March 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroparesis
    Keywords
    Cystic Fibrosis, Pediatrics, Altered lung function

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cystic Fibrosis
    Arm Type
    Experimental
    Arm Description
    Patients who are diagnosed with Cystic Fibrosis.
    Arm Title
    Healthy Normal
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis.
    Intervention Type
    Device
    Intervention Name(s)
    13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rate of gastric emptying
    Description
    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.
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Rate of gastric emptying over time
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daphna Katz, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gastroparesis in Cystic Fibrosis

    We'll reach out to this number within 24 hrs