User Testing of the Evivo Screening Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-04-24

Brief Summary

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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.

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Detailed Description

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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

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Gut Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Infants less than 6 months of age

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.

Group Type OTHER

Evivo Infant Gut Bifidobacterium Screening Test

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes