User Testing of the Evivo Screening Test

Evolve BioSystems

Status: Terminated

Conditions: Gut Microbiome

Treatments: Device: Evivo Infant Gut Bifidobacterium Screening Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03601936

EV-8601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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231 participants in 1 patient group

Infants less than 6 months of age

Other group

Description:

The Evivo Infant Gut Bifidobacterium Screening Test study is a single-group interventional study of 600 female and male infants who are less than 6 months of age and generally healthy.

Treatment:

Device: Evivo Infant Gut Bifidobacterium Screening Test