User Testing of the Evivo Screening Test

Not Applicable

Terminated

• Conditions: Gut Microbiome
• Interventions: Device: Evivo Infant Gut Bifidobacterium Screening Test

• Registration Number: NCT03601936
• Lead Sponsor: Evolve BioSystems, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-07-26
• Study Start: 2018-08-01
• Primary Completion: 2019-04-24
• Study Completion: 2019-04-24
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infants less than 6 months of age	Evivo Infant Gut Bifidobacterium Screening Test	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens compared to molecular methods (quantitative PCR).	2 - 6 weeks	The primary objective of this CLIA Waiver User Testing study is to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test 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.

Secondary Outcome Measures

Name	Time	Method
Ease of use of the Evivo Screening Test by operators.	2 - 6 weeks	Operators will be asked to complete Operator Questionnaires about their experience using the Screening Test. A 5-point Likert scale will be used to measure outcomes (1 for strongly disagree and 5 for strongly agree). Lower values will represent a worse outcome.

Trial Locations

Locations (5)

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

Swarthmore Pediatrics; 🇺🇸 Swarthmore, Pennsylvania, United States

Matrix Clinical Research, Inc.; 🇺🇸 Los Angeles, California, United States

Breastfeed Atlanta LLC; 🇺🇸 Marietta, Georgia, United States

Coastal Pediatric Research; 🇺🇸 Charleston, South Carolina, United States