Gut MicrobiomeNCT03601936
User Testing of the Evivo Screening Test
A study testing Evivo Infant Gut Bifidobacterium Screening Test in people with Gut Microbiome, run by Evolve BioSystems, Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- Evivo Infant Gut Bifidobacterium Screening Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2018to 24 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 0-6 months.
- Generally healthy infants.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Coastal Pediatric Research
Charleston, South Carolina, 29414
Cyn3rgy Research
Gresham, Oregon, 97030
Matrix Clinical Research, Inc.
Los Angeles, California, 90057
Breastfeed Atlanta LLC
Marietta, Georgia, 30060
Swarthmore Pediatrics
Swarthmore, Pennsylvania, 19081
About this study
Official title: User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
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.
Read the 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.
- Conditions
- Gut Microbiome
- Being tested
- Evivo Infant Gut Bifidobacterium Screening Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evivo Infant Gut Bifidobacterium Screening TestDevice
Operators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol.
| Study group | Role | What they receive |
|---|---|---|
| Infants less than 6 months of age | Other | 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. Receives: Device: Evivo Infant Gut Bifidobacterium Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 - 6 weeks
Secondary outcomes (1)
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.
Measured: 2 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Why it stopped: Additional in-house analysis and development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve BioSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Flannery, Study director, rflannery@evolvebiosystems.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601936
- Sponsor's protocol ID
- EV-8601
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
- ClinicalTrials.gov ID
- NCT03601936
- Acronym / sponsor ID
- EV-8601
- Conditions
- Gut Microbiome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Additional in-house analysis and development
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Evolve BioSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants less than 6 months of age | Other | Device: Evivo Infant Gut Bifidobacterium Screening TestThe 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants aged 0-6 months.
- Generally healthy infants.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evivo Infant Gut Bifidobacterium Screening TestOperators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol. | Device | Infants less than 6 months of age |
Primary outcome
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.
1 secondary outcome
Ease of use of the Evivo Screening Test by operators.
Time frame: 2 - 6 weeks
Results and safety
The study was stopped early (reason given: Additional in-house analysis and development). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Gut Microbiome
Not yet recruitingPhase 4
Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis
Cholangitis, Ascending Cholangitis
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
Periodontitis (Stage 3), Periodontitis Stage IV
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
Recruiting
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Flannery study director
rflannery@evolvebiosystems.com
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evivo Infant Gut Bifidobacterium Screening Test in people with Gut Microbiome, run by Evolve BioSystems, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Additional in-house analysis and development). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.