The EFFECT Study: Probiotic and HMO Supplementation in Infants

NCT03994315 | Completed

• 1 other identifier: EV-8901
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial bacteria (bifidobacteria, in particular) in the infant gut. Exclusively formula-fed infants lack HMOs in their diet in the absence of naturally occurring HMOs from breast milk. The proposed clinical study will evaluate the ability of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B. infantis EVC001) in exclusively formula-fed infants. B. infantis EVC001 has been shown to be well-tolerated and safely consumed in breastfed infants. This study also aims to evaluate the safety and tolerability of LNT in different doses when consumed daily with B. infantis EVC001.

Conditions

Infant Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• B. infantis levels in infant stool

  To evaluate the ability of different doses of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B. infantis EVC001) in exclusively formula-fed infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.

  Baseline, Days 1-35, Day 40

Secondary Outcomes (4)

• Total infant gut microbiome modulation

  Baseline, Days 5, 12, 19, 26, 40

• Frequency of adverse events

  During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)

• Frequency of gastrointestinal symptoms warranting a doctor's visit

  During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)

• Frequency of adverse events resulting in withholding or discontinuing the study products

  During supplementation (Day 1 to Day 28)

Study Arms (3)

B. infantis EVC001 + LNT (3 g/L then 8 g/L)

EXPERIMENTAL

Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10\^9 CFU) mixed with infant formula for 28 consecutive days. Group 1 \[B. infantis + LNT (3 g/L then 8 g/L)\] will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their infant formula for every formula preparation during the 28-day supplementation period. They will receive a concentration of 3 g/L for 2 weeks followed by 8 g/L for the next 2 weeks, without a washout period in between.

Other: B. infantis EVC001; Other: Lacto-N-tetraose (LNT)

B. infantis EVC001 + LNT (6 g/L then 12 g/L)

EXPERIMENTAL

Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10\^9 CFU) mixed with infant formula for 28 consecutive days. Group 2 \[B. infantis + LNT (6 g/L then 12 g/L)\] will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their infant formula for every formula preparation during the 28-day supplementation period. They will receive a concentration of 6 g/L for 2 weeks followed by 12 g/L for the next 2 weeks, without a washout period in between.

Other: B. infantis EVC001; Other: Lacto-N-tetraose (LNT)

B. infantis EVC001 alone

ACTIVE COMPARATOR

Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10\^9 CFU) mixed with infant formula for 28 consecutive days.

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

B. infantis EVC001 + LNT (3 g/L then 8 g/L); B. infantis EVC001 + LNT (6 g/L then 12 g/L); B. infantis EVC001 alone

Lacto-N-tetraose (LNT) OTHER

LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.

B. infantis EVC001 + LNT (3 g/L then 8 g/L); B. infantis EVC001 + LNT (6 g/L then 12 g/L)

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant is between 0 and 60 days of life at the time of enrollment
• Infant is exclusively formula-fed with caregiver intent to continue exclusive formula feeding for the duration of the study (at least 7 weeks)
• Infant is consuming cow's milk-based formula without probiotics
• Term infant, born \>37 weeks gestation
• Infant is healthy and without medical complications
• Infant's caregivers are willing to refrain from feeding their infant breast milk, solid foods, and non-study probiotics prior to study completion

You may not qualify if:

• Infant was born with medical complications such as respiratory distress syndrome or birth defects
• Infant has any gastrointestinal tract abnormalities
• Infant has been diagnosed with failure to thrive
• Infant has taken oral or IV antibiotics or antifungals within 4 weeks of enrollment or during the Lead-in Period
• Infant is consuming partially hydrolyzed or extensively hydrolyzed infant formula because of gastrointestinal disturbance or gassiness/fussiness
• Infant has consumed any breast milk within 7 days of enrollment or during the Lead-in Period
• Infant has consumed any probiotics containing B. infantis since birth
• Infant has consumed any Bifidobacterium-containing probiotics within 2 weeks of enrollment or during the Lead-in Period
• Infant's caregivers plan to feed them any breast milk, solid foods, or non-study probiotics at any time throughout the duration of the study
• Infant was born in a multiple birth
• Infant lives in more than one location
• Any infant who the investigator feels is not an appropriate study participant

Sponsors & Collaborators

• Evolve BioSystems, Inc.: lead

Study Sites (1)

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

MeSH Terms

Interventions

lacto-N-neotetraose

Study Officials

• Rimon Youssef, MD

  Coastal Pediatric Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This study is a single-center, prospective, randomized, open-label study of an infant probiotic (B. infantis EVC001) and a prebiotic supplement (LNT) in exclusively formula-fed infants. Nine subjects will be randomized (1:1:1) using sealed envelopes into three treatment arms.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 12, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)