NCT05223881
Withdrawn
Not Applicable
13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
ConditionsGastroparesis
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Primary Endpoint
- Rate of gastric emptying
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Rate of gastric emptying
Time Frame: 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 Outcomes
- Rate of gastric emptying over time(6 months)
Investigators
Daphna Katz
Pediatric Gastroenterology Fellow
University of Miami
Similar Trials
Completed
Not Applicable
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)DyspepsiaNCT01248221Mayo Clinic30
Completed
Not Applicable
Pilot study: Gastric emptying with 13C breath testanorexia verlies van eetlust10003018NL-OMON31414Wageningen Universiteit10
Completed
Not Applicable
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)GastroparesisNCT06004596Cairn Diagnostics182
Completed
Not Applicable
Novel Breath Test to Detect Early Stage Chronic PancreatitisChronic PancreatitisNCT01184573Metabolic Solutions Inc.50
Completed
Early Phase 1
13C Trioctanoate Breath Test as a Measurement of Gastric Fat Volume EmptyingHealthyNCT02602158University of Zurich32