13C-Spirulina Nitrogen Content GEBT Study

Sponsor

Cairn Diagnostics (Industry)

Overall Status

Terminated

CT.gov ID

NCT04635306

Collaborator

(none)

Enrollment

Location

Arm

8.1

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Diagnostic Test: Approved GEBT test meal	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 21, 2020

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Jun 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Nitrogen GEBT test meal GEBT test meal containing low %N content (below 7%)	Diagnostic Test: Approved GEBT test meal FDA-approve GEBT test meal

Arm

Intervention/Treatment

Experimental: Low Nitrogen GEBT test meal

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

Diagnostic Test: Approved GEBT test meal

FDA-approve GEBT test meal

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairn Diagnostics	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

Cairn Diagnostics

Investigators

Principal Investigator: Alex Ryder, MD, PhD, Cairn Diagnostics

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jul 16, 2020

More Information

Publications

None provided.

Responsible Party:

Cairn Diagnostics

ClinicalTrials.gov Identifier:

NCT04635306

Other Study ID Numbers:

PRO-CD-041

First Posted:

Nov 19, 2020

Last Update Posted:

Aug 3, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Cairn Diagnostics

Gastroenterology

Gastric emptying breath test

Additional relevant MeSH terms:

Gastroparesis

Study Results

No Results Posted as of Aug 3, 2021