NCT03939546

The FOUNDATION Study

The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Evolve BioSystems, Inc. · Industry
• Sex: All
• Age: 10 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infant

Interventions

Type	Name	Description
OTHER	B. infantis EVC001	Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)

Timeline

• Start date: 2019-07-03
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-05-07
• Last updated: 2021-06-30

Locations

1 site across 1 country: United States