Back to results13C-Spirulina Nitrogen Content GEBT Study
Primary Purpose
Gastroparesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Approved GEBT test meal
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroparesis focused on measuring Gastroenterology, Gastric emptying breath test
Eligibility Criteria
Inclusion Criteria:
- Males and females, 18-85 years old at time of signing consent form
- Ability to eat test meal and provide breath samples
Exclusion Criteria:
- History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
- Symptoms consistent with delayed gastric emptying
- History of abdominal surgery except appendectomy
- Use of any medications that may alter gastric motility within two days of the study
- Use of narcotics or anticholinergics within two days of the study
- Females on hormone replacement therapy other than birth control medications
- Receipt of an investigational drug within 4 weeks of the study
- Pregnancy
- Intolerance or allergy to any component of Gastric Emptying Breath Test meal
- History of neurologic or psychiatric disorder
Sites / Locations
- Cairn Diagnostics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Nitrogen GEBT test meal
Arm Description
GEBT test meal containing low %N content (below 7%)
Outcomes
Primary Outcome Measures
Difference in vivo 13C-Spirulina GEBT response
Determining the difference between measure gastric emptying rate (kPCD) results produced from the low %N 13C-Spirulina GEBT test meal and the FDA-approved test meal
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04635306
Brief Title
13C-Spirulina Nitrogen Content GEBT Study
Official Title
Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test (GEBT) Results
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Initial results showed no equivalence between GEBT test meals with low nitrogen versus a standard GEBT test meal
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cairn Diagnostics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).
Detailed Description
In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% Nitrogen content will be administered. Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling. The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroenterology, Gastric emptying breath test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Nitrogen GEBT test meal
Arm Type
Experimental
Arm Description
GEBT test meal containing low %N content (below 7%)
Intervention Type
Diagnostic Test
Intervention Name(s)
Approved GEBT test meal
Intervention Description
FDA-approve GEBT test meal
Primary Outcome Measure Information:
Title
Difference in vivo 13C-Spirulina GEBT response
Description
Determining the difference between measure gastric emptying rate (kPCD) results produced from the low %N 13C-Spirulina GEBT test meal and the FDA-approved test meal
Time Frame
Up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females, 18-85 years old at time of signing consent form
Ability to eat test meal and provide breath samples
Exclusion Criteria:
History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
Symptoms consistent with delayed gastric emptying
History of abdominal surgery except appendectomy
Use of any medications that may alter gastric motility within two days of the study
Use of narcotics or anticholinergics within two days of the study
Females on hormone replacement therapy other than birth control medications
Receipt of an investigational drug within 4 weeks of the study
Pregnancy
Intolerance or allergy to any component of Gastric Emptying Breath Test meal
History of neurologic or psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Ryder, MD, PhD
Organizational Affiliation
Cairn Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairn Diagnostics
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
13C-Spirulina Nitrogen Content GEBT Study
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