13C-Spirulina Nitrogen Content GEBT Study

Gastroparesis Clinical Trial

Official title:

Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test (GEBT) Results

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04635306
• Other study ID #: PRO-CD-041
• Status: Terminated
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: July 2021
• Source: Cairn Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Diagnostic Test:
• Approved GEBT test meal
FDA-approve GEBT test meal

Locations

Country	Name	City	State
United States	Cairn Diagnostics	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cairn Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 2 weeks