NCT04772261

GEBT Lot-to-Lot and Biological Variability

13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cairn Diagnostics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.

Detailed description

In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	13C-Spirulina GEBT	Various lots of 13C-Spirulina GEBT test meals

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-01-10
• Completion: 2022-01-10
• First posted: 2021-02-26
• Last updated: 2022-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study