An interventional study of B. infantis EVC001 in Preterm Infant, sponsored by Evolve BioSystems, Inc.. Completed at 1 site in United States. Open to participants aged Up to 10 Days. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Evolve BioSystems, Inc. · Not applicable, Interventional, and Other
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Evolve BioSystems, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: B. infantis EVC001
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Also known as: Evivo with MCT Oil
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.
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
Plan to share: No
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Evolve BioSystems, Inc.