User Testing of the Evivo Screening Test

Stopped early · Not applicable

Conditions studied: Gut Microbiome

In brief

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.

Key facts

Study ID

NCT03601936

Run by

Evolve BioSystems, Inc.

People needed

231

Starts

2018-08-01

Expected to finish

2019-04-24

Last updated by the study team

2019-07-23

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infants aged 0-6 months.
• Generally healthy infants.

You may not qualify if…

• Infants should not have an acute infection.
• Not intended for use with stool containing meconium.
• Infants with jaundice should not be tested until it has resolved.
• This test should not be used for infants with carbohydrate malabsorption syndrome, which may present with one or more of the following persistent signs: abnormally foul-smelling, mucus-containing, and/or green frothy stools.

Where it is running

• Matrix Clinical Research, Inc. — Los Angeles, California, United States
• Breastfeed Atlanta LLC — Marietta, Georgia, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Swarthmore Pediatrics — Swarthmore, Pennsylvania, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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