13C-Spirulina Nitrogen Content GEBT Study

NCT04635306 | Terminated FDA Device

• 1 other identifier: PRO-CD-041
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroparesis

Keywords

Gastroenterology; Gastric emptying breath test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Low Nitrogen GEBT test meal

EXPERIMENTAL

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

Diagnostic Test: Approved GEBT test meal

Interventions

Approved GEBT test meal DIAGNOSTIC_TEST

FDA-approve GEBT test meal

Low Nitrogen GEBT test meal

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18-85 years old at time of signing consent form
• Ability to eat test meal and provide breath samples

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairn Diagnostics: lead

Study Sites (1)

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Ryder, MD, PhD

  Cairn Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: October 21, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)