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The FOUNDATION Study — FOUNDATION  

Preterm Infant Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03939546
Study type Interventional
Source Evolve BioSystems, Inc.
Contact
Status Completed
Phase N/A
Start date July 3, 2019
Completion date June 1, 2021
View Details
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