Preterm InfantFOUNDATIONNCT03939546
The FOUNDATION Study
A study testing B. infantis EVC001 in people with Preterm Infant, run by Evolve BioSystems, Inc. at 1 site in United States.
Trial summary
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant… Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Preterm Infant
- What is being tested?
- B. infantis EVC001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 1 Jun 2021
- 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 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks
- ≤ 10 days of life and considered viable
- Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
- Toleration of 1.0 mL bolus enteral feeds
Who cannot join
- Presence of septicemia or active infection as determined by positive 48-hour blood cultures
- Necrotizing enterocolitis
- Pulmonary hypoplasia
- Presence of clinically significant congenital heart disease or other major congenital malformation
- Any infant the Investigator deems to be ineligible for participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806
About this study
Official title: The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.
Read the detailed description
This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.
- Conditions
- Preterm Infant
- Being tested
- B. infantis EVC001
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis EVC001Other
Also called Evivo with MCT Oil
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care. |
| B. infantis EVC001 | Active comparator | Infants in the B. infantis arm will receive a once daily enteral feed of Evivo with MCT oil (8B CFU B. infantis EVC001) from Study Day 0 (by Day 10 of life) to hospital discharge, except on days when the infant is NPO. Receives: Other: B. infantis EVC001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability: Frequency of Adverse Events
Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability: Frequency of Blood in Stool
Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability: Frequency of Abdominal Distension
Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability: Frequency of Emesis
Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability: Frequency of disruption in skin integrity in diaper area
Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.
Measured: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Secondary outcomes (3)
B. infantis levels in preterm infant stool related to probiotic supplementation
Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.
Measured: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Bifidobacterium levels in preterm infant stool related to probiotic supplementation
Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of Bifidobacterium.
Measured: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Changes in the preterm gut microbiome over time related to probiotic supplementation
Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA and RNA will be extracted from stool swab samples and will be used for next generation sequencing to determine relative abundance of the most abundant bacterial taxa.
Measured: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start3 Jul 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a single-center, open-label, prospective, cohort study. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve BioSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Bajorek, MD, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939546
- Sponsor's protocol ID
- EV-8801
- Acronym
- FOUNDATION
- Status last verified
- Jun 2021
- First submitted
- 25 Apr 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
- ClinicalTrials.gov ID
- NCT03939546
- Acronym / sponsor ID
- FOUNDATION / EV-8801
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Evolve BioSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 7 May 2019 (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 FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.
Detailed description
This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, open-label, prospective, cohort study. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care. |
| B. infantis EVC001 | Active comparator | Other: B. infantis EVC001Infants in the B. infantis arm will receive a once daily enteral feed of Evivo with MCT oil (8B CFU B. infantis EVC001) from Study Day 0 (by Day 10 of life) to hospital discharge, except on days when the infant is NPO. |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks
- ≤ 10 days of life and considered viable
- Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
- Toleration of 1.0 mL bolus enteral feeds
Key exclusion criteria (5 listed)
- Presence of septicemia or active infection as determined by positive 48-hour blood cultures
- Necrotizing enterocolitis
- Pulmonary hypoplasia
- Presence of clinically significant congenital heart disease or other major congenital malformation
- Any infant the Investigator deems to be ineligible for participation
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 |
|---|---|---|
| B. infantis EVC001Also: Evivo with MCT OilBifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU) | Other | B. infantis EVC001 |
Primary outcome
Tolerability: Frequency of Adverse Events
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.
Tolerability: Frequency of Blood in Stool
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.
Tolerability: Frequency of Abdominal Distension
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.
Tolerability: Frequency of Emesis
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.
Tolerability: Frequency of disruption in skin integrity in diaper area
Time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.
3 secondary outcomes
B. infantis levels in preterm infant stool related to probiotic supplementation
Time frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Bifidobacterium levels in preterm infant stool related to probiotic supplementation
Time frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Changes in the preterm gut microbiome over time related to probiotic supplementation
Time frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Sarah Bajorek, MD principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. infantis EVC001 in people with Preterm Infant, run by Evolve BioSystems, Inc. at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tolerability: Frequency of Adverse Events (time frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.). The study lists 6 primary outcomes in all. 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 30 Jun 2021.