User Testing of the Evivo Screening Test

Gut Microbiome Clinical Trial

Official title:

User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03601936
• Other study ID #: EV-8601
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 24, 2019

Study information

• Verified date: July 2019
• Source: Evolve BioSystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 231
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiome

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Evolve BioSystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	2 - 6 weeks
Secondary	Ease of use of the Evivo Screening Test by operators.	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.	2 - 6 weeks