A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis

NCT04662619 | Completed DMC

• 1 other identifier: CCSNUT002443
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Atopic Dermatitis (AD) through Week 52

  Percentage of participants with atopic dermatitis (AD) through Week 52 will be reported. AD will be diagnosed if three of the following four criteria are met: 1) pruritus, 2) typical morphology and distribution (facial and extensor involvement), 3) chronic or chronically relapsing dermatitis, 4) personal or family history of atopic disease.

  Up to Week 52

Secondary Outcomes (8)

• Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104

  Up to Weeks 12, 52 and 104

• Percentage of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104

  Up to Weeks 24 and 104

• Time to Onset of AD Through Weeks 52 and 104

  Up to Weeks 52 and 104

• Percentage of Infants with B. infantis Gut Colonization at Week 12

  Week 12

• Percentage of Participants with at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score at Weeks 12, 52, and 104

  At Weeks 12, 52, and 104

Study Arms (2)

B. infantis

EXPERIMENTAL

A once-daily feeding of activated B. infantis EVC001 (8.0 \*10\^9 colony forming units \[CFU\]) will be provided to infants for 12 weeks.

Other: B. infantis

Placebo

PLACEBO COMPARATOR

A once-daily oral feeding of lactose placebo will be provided to infants for 12 weeks.

Other: Lactose Placebo

Interventions

B. infantis OTHER

Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks.

Also known as: Evivo

B. infantis

Lactose Placebo OTHER

Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy term infant
• Has at least one first degree relative (that is biological parent or full sibling) with a history of atopic disease (that is mother-reported, physician-diagnosed Atopic Dermatitis (AD), allergic rhinitis, or asthma)
• Breastfeeding established (as determined by the principal Investigator \[PI\] or designee) at the time of study enrollment (Day 0), with maternal intent to maintain exclusive breastfeeding for greater than or equal to (\>=)12 weeks
• Will participate in the study under supervision of his/her biological mother ("Caregiver") who is: a) At least 18 years old b) The legal guardian of the infant c) Intending to cohabitate with the infant for the duration of the study d) Willing to follow all Caregiver responsibilities e) Fluent in Finnish, Swedish, or English
• The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with antenatal appointments and agreement to complete the intuitive, interactive, electronic diary (eDiary) utilizing personal smart device (example, tablet, cell phone)

You may not qualify if:

• Preterm delivery (\< 36 weeks \[252 days\] gestational age)
• Admission to the neonatal unit for issues other than establishment of normal feeding
• Evidence of a baseline illness/condition (example abnormal birth weight) or significant risk of developing an illness/condition (based on review of maternal/pregnancy information) that would, in the opinion of the Principal Investigator (PI) or designee, introduce a significant safety concern if the infant were enrolled in the study or otherwise preclude study participation
• Significant birth defect/complication that would, in the opinion of the PI or designee, create a safety concern or otherwise confound the study (example, abdominal wall defects, congenital heart disease)
• Severe widespread skin condition (example collodion)
• Has consumed greater than (\>)100 milliliter (mL) of formula per day within the 48 hours prior to enrollment (Day 0)
• Twin or multiple births
• Atopic dermatitis (AD) diagnosed at Day 0
• Has a history of confirmed coronavirus disease 2019 (COVID-19) within 30 days prior to any on-site visit
• Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has a confirmed case of COVID-19
• Is under a COVID-19 isolation/quarantine order
• Has had self-reported (for Caregiver) or parent-reported (for infant) symptoms of COVID-19 within 14 days prior to the screening visit, such as unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead
• Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.): collaborator

Study Sites (1)

HUS Children and Adolescents, Clinical Trial Unit, Park Hospital

Helsinki, 00290, Finland

Location

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Study Officials

• Samuli Rautava, M.D., Ph.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 10, 2020
• Study Start: December 18, 2020
• Primary Completion: December 7, 2023
• Study Completion: November 19, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)