The FOUNDATION Study

Completed · Not applicable

Conditions studied: Preterm Infant

In brief

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.

Key facts

Study ID

NCT03939546

Run by

Evolve BioSystems, Inc.

People needed

30

Starts

2019-07-03

Expected to finish

2021-06-01

Last updated by the study team

2021-06-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Health Winnie Palmer Hospital for Women & Babies — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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