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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2024
  • participants needed
    286
  • sponsor
    Johnson & Johnson Consumer Inc. (J&JCI)
Updated on 17 June 2022
Accepts healthy volunteers

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.

Details
Condition Healthy
Treatment B. infantis, Lactose Placebo
Clinical Study IdentifierNCT04662619
SponsorJohnson & Johnson Consumer Inc. (J&JCI)
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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