The FOUNDATION Study

Preterm Infant Clinical Trial

— FOUNDATION  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03939546
• Other study ID #: EV-8801
• Status: Completed
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Evolve BioSystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

Inclusion Criteria:

1. Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks

2. = 10 days of life and considered viable

3. Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment

4. Toleration of 1.0 mL bolus enteral feeds

Exclusion Criteria:

1. Presence of septicemia or active infection as determined by positive 48-hour blood cultures

2. Necrotizing enterocolitis

3. Pulmonary hypoplasia

4. Presence of clinically significant congenital heart disease or other major congenital malformation

5. Any infant the Investigator deems to be ineligible for participation

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• B. infantis EVC001
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)

Locations

Country	Name	City	State
United States	Orlando Health Winnie Palmer Hospital for Women & Babies	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Evolve BioSystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	B. infantis levels in preterm infant stool related to probiotic supplementation	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.	Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Secondary	Bifidobacterium levels in preterm infant stool related to probiotic supplementation	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.	Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age
Secondary	Changes in the preterm gut microbiome over time related to probiotic supplementation	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.	Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age