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User Testing of the Evivo Screening Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601936
Recruitment Status : Terminated (Additional in-house analysis and development)
First Posted : July 26, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Evolve BioSystems, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gut Microbiome Device: Evivo Infant Gut Bifidobacterium Screening Test Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 24, 2019
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. Ease of use of the Evivo Screening Test by operators. [ Time Frame: 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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601936


Locations
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United States, California
Matrix Clinical Research, Inc.
Los Angeles, California, United States, 90057
United States, Georgia
Breastfeed Atlanta LLC
Marietta, Georgia, United States, 30060
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Swarthmore Pediatrics
Swarthmore, Pennsylvania, United States, 19081
United States, South Carolina
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
Sponsors and Collaborators
Evolve BioSystems, Inc.
Investigators
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Study Director: Robin Flannery rflannery@evolvebiosystems.com
More Information
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Responsible Party: Evolve BioSystems, Inc.
ClinicalTrials.gov Identifier: NCT03601936    
Other Study ID Numbers: EV-8601
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No