The FOUNDATION Study

Evolve BioSystems

Status: Completed

Conditions: Preterm Infant

Treatments: Other: B. infantis EVC001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03939546

EV-8801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: Under 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

No Intervention group

Description:

The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care.

B. infantis EVC001

Active Comparator group

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.

Treatment:

Other: B. infantis EVC001