Study Stopped
Additional in-house analysis and development
User Testing of the Evivo Screening Test
User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
1 other identifier
interventional
231
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedJuly 23, 2019
July 1, 2019
9 months
July 16, 2018
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (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).
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 Outcomes (1)
Ease of use of the Evivo Screening Test by operators.
2 - 6 weeks
Study Arms (1)
Infants less than 6 months of age
OTHERThe 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.
Interventions
Operators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol.
Eligibility Criteria
You may qualify if:
- Infants aged 0-6 months.
- Generally healthy infants.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Matrix Clinical Research, Inc.
Los Angeles, California, 90057, United States
Breastfeed Atlanta LLC
Marietta, Georgia, 30060, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Swarthmore Pediatrics
Swarthmore, Pennsylvania, 19081, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Study Officials
- STUDY DIRECTOR
Robin Flannery
rflannery@evolvebiosystems.com
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2018
First Posted
July 26, 2018
Study Start
August 1, 2018
Primary Completion
April 24, 2019
Study Completion
April 24, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07