Gut Microbiome
Conditions
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.
Interventions
DEVICEEvivo 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.
Sponsors
Evolve BioSystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed