13C-Spirulina Nitrogen Content GEBT Study

NCT ID: NCT04635306

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2021-06-25

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Low Nitrogen GEBT test meal

GEBT test meal containing low %N content (below 7%)

Group Type: EXPERIMENTAL

Approved GEBT test meal

Intervention Type: DIAGNOSTIC_TEST

FDA-approve GEBT test meal

Interventions

Approved GEBT test meal

FDA-approve GEBT test meal

Intervention Type: DIAGNOSTIC_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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairn Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Ryder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairn Diagnostics

Locations

Cairn Diagnostics

Brentwood, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO-CD-041

Identifier Type: -

Identifier Source: org_study_id