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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, United States
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.
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: 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.
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: 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.
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: 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.
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: 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.
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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: 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.
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.
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.
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
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
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.
Time frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age