Gastroparesis in Cystic Fibrosis

University of Miami

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Gastroparesis

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.

Eligibility

Sex: ALLMin age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4 hours

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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