13C-Spirulina Nitrogen Content GEBT Study

Not Applicable

Terminated

• Conditions: Gastroparesis
• Interventions: Diagnostic Test: Approved GEBT test meal

• Registration Number: NCT04635306
• Lead Sponsor: Cairn Diagnostics

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.

Study Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Primary Completion: 2021-06-25
• Study Completion: 2021-06-25
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Nitrogen GEBT test meal	Approved GEBT test meal	GEBT test meal containing low %N content (below 7%)

Primary Outcome Measures

Name	Time	Method
Difference in vivo 13C-Spirulina GEBT response	Up to 2 weeks	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

Trial Locations

Locations (1)

Cairn Diagnostics; 🇺🇸 Brentwood, Tennessee, United States