The FOUNDATION Study

NCT03939546 | Completed

• 1 other identifier: EV-8801
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (6)

• Tolerability: Frequency of Adverse Events

  Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.

  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.

• Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator

  Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.

  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.

• Tolerability: Frequency of Blood in Stool

  Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.

  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.

• Tolerability: Frequency of Abdominal Distension

  Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.

  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.

• Tolerability: Frequency of Emesis

  Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.

  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.

• Tolerability: Frequency of disruption in skin integrity in diaper area

  Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.

  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 (3)

• B. infantis levels in preterm infant stool related to probiotic supplementation

  Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age

• Bifidobacterium levels in preterm infant stool related to probiotic supplementation

  Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age

• Changes in the preterm gut microbiome over time related to probiotic supplementation

  Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age

Study Arms (2)

Control

NO INTERVENTION

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

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.

Other: B. infantis EVC001

Interventions

B. infantis EVC001 OTHER

Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)

Also known as: Evivo with MCT Oil

B. infantis EVC001

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Evolve BioSystems, Inc.: lead

Study Sites (1)

Orlando Health Winnie Palmer Hospital for Women & Babies

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sarah Bajorek, MD

  Orlando Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 7, 2019
• Study Start: July 3, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)