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Completed

NCT Number: NCT03939546

The FOUNDATION Study

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health Winnie Palmer Hospital for Women & Babies

Orlando, Florida, 32806, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

B. infantis EVC001

Other

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

Other names: Evivo with MCT Oil

Primary outcomes

  1. Tolerability: Frequency of Adverse Events

    Time frame: 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 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.

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

    Time frame: 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 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.

  3. Tolerability: Frequency of Blood in Stool

    Time frame: 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 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.

  4. Tolerability: Frequency of Abdominal Distension

    Time frame: 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 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.

  5. Tolerability: Frequency of Emesis

    Time frame: 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 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.

  6. Tolerability: Frequency of disruption in skin integrity in diaper area

    Time frame: 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 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.

Secondary outcomes

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

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

    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.

  2. Bifidobacterium levels in preterm infant stool related to probiotic supplementation

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

    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of Bifidobacterium.

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

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

    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA and RNA will be extracted from stool swab samples and will be used for next generation sequencing to determine relative abundance of the most abundant bacterial taxa.

Sponsors and collaborators

Lead sponsor

Evolve BioSystems, Inc.

Industry

Registry information

Official study title

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

Acronym: FOUNDATION

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 7, 2019
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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