The FOUNDATION Study
- Conditions
- Preterm Infant
- Registration Number
- NCT03939546
- Lead Sponsor
- Evolve BioSystems, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator 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 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 disruption in skin integrity in diaper area 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.
Tolerability: Frequency of Abdominal Distension 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 Adverse Events 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 Emesis 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.
- Secondary Outcome Measures
Name Time Method Changes in the preterm gut microbiome over time related to probiotic supplementation Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age 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.
B. infantis levels in preterm infant stool related to probiotic supplementation Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age 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 Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age 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.
Trial Locations
- Locations (1)
Orlando Health Winnie Palmer Hospital for Women & Babies
🇺🇸Orlando, Florida, United States
Orlando Health Winnie Palmer Hospital for Women & Babies🇺🇸Orlando, Florida, United States