Back to resultsThe FOUNDATION Study (FOUNDATION)
Primary Purpose
Preterm Infant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B. infantis EVC001
Sponsored by
About this trial
This is an interventional other trial for Preterm Infant
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Orlando Health Winnie Palmer Hospital for Women & Babies
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
B. infantis EVC001
Arm Description
The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03939546
Brief Title
The FOUNDATION Study
Acronym
FOUNDATION
Official Title
The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evolve BioSystems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care.
Arm Title
B. infantis EVC001
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
B. infantis EVC001
Other Intervention Name(s)
Evivo with MCT Oil
Intervention Description
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Primary Outcome Measure Information:
Title
Tolerability: Frequency of Adverse Events
Description
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.
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.
Title
Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
Description
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.
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.
Title
Tolerability: Frequency of Blood in Stool
Description
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.
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.
Title
Tolerability: Frequency of Abdominal Distension
Description
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.
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.
Title
Tolerability: Frequency of Emesis
Description
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.
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.
Title
Tolerability: Frequency of disruption in skin integrity in diaper area
Description
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.
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.
Secondary Outcome Measure Information:
Title
B. infantis levels in preterm infant stool related to probiotic supplementation
Description
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.
Time Frame
Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Title
Bifidobacterium levels in preterm infant stool related to probiotic supplementation
Description
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.
Time Frame
Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Title
Changes in the preterm gut microbiome over time related to probiotic supplementation
Description
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.
Time Frame
Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Bajorek, MD
Organizational Affiliation
Orlando Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health Winnie Palmer Hospital for Women & Babies
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The FOUNDATION Study
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