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User Testing of the Evivo Screening Test

NCT03601936 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2019-07-23

No results posted yet for this study

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.

Conditions

  • Gut Microbiome

Interventions

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.

Sponsors & Collaborators

  • Evolve BioSystems, Inc.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-04-24
Completion
2019-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601936 on ClinicalTrials.gov