Clinical trial NCT03939546: The FOUNDATION 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Lead sponsor: Evolve BioSystems, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 30
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Birth weight \< 1500 grams or gestational age at birth \< 33 and 0/7 weeks
2. ≤ 10 days of life and considered viable
3. Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
4. Toleration of 1.0 mL bolus enteral feeds

Exclusion Criteria:

1. Presence of septicemia or active infection as determined by positive 48-hour blood cultures
2. Necrotizing enterocolitis
3. Pulmonary hypoplasia
4. Presence of clinically significant congenital heart disease or other major congenital malformation
5. Any infant the Investigator deems to be ineligible for participation

Primary outcomes:
measure: Tolerability: Frequency of Adverse Events
timeFrame: 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.
measure: Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
timeFrame: 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.
measure: Tolerability: Frequency of Blood in Stool
timeFrame: 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.
measure: Tolerability: Frequency of Abdominal Distension
timeFrame: 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.
measure: Tolerability: Frequency of Emesis
timeFrame: 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.
measure: Tolerability: Frequency of disruption in skin integrity in diaper area
timeFrame: 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:
measure: B. infantis levels in preterm infant stool related to probiotic supplementation
timeFrame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
measure: Bifidobacterium levels in preterm infant stool related to probiotic supplementation
timeFrame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
measure: Changes in the preterm gut microbiome over time related to probiotic supplementation
timeFrame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health Winnie Palmer Hospital for Women & Babies
state: Florida
Study officials:
affiliation: Orlando Health
name: Sarah Bajorek, MD
role: PRINCIPAL_INVESTIGATOR
References: