NCT03601936

User Testing of the Evivo Screening Test

User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Evolve BioSystems, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

Detailed description

This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium Screening Test ("Evivo Screening Test"). Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was designed to differentiate between high and low levels of Bifidobacterium in infant stool. This study is intended to confirm the precision of results for this screening test, as well as its ease of use, in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.

Conditions

• Gut Microbiome

Interventions

Type	Name	Description
DEVICE	Evivo Infant Gut Bifidobacterium Screening Test	Operators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-04-24
• Completion: 2019-04-24
• First posted: 2018-07-26
• Last updated: 2019-07-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study