Status:
COMPLETED
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Collaborating Sponsors:
Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)
Conditions:
Healthy
Eligibility:
All Genders
Up to 14 years
Phase:
NA
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 incid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT04662619
Start Date
December 18 2020
End Date
November 19 2024
Last Update
December 16 2024
Active Locations (1)
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1
HUS Children and Adolescents, Clinical Trial Unit, Park Hospital
Helsinki, Finland, 00290