Clinical trial NCT04662619: A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Official title: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Nutritional Intervention Study to Examine the Clinical and Immunological Effects of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)
First posted: 2020-12-10
Enrollment: 273
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Atopic Dermatitis (AD) through Week 52
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104
timeFrame: Up to Weeks 12, 52 and 104
measure: Percentage of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104
timeFrame: Up to Weeks 24 and 104
measure: Time to Onset of AD Through Weeks 52 and 104
timeFrame: Up to Weeks 52 and 104
measure: Percentage of Infants with B. infantis Gut Colonization at Week 12
timeFrame: Week 12
measure: 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
timeFrame: At Weeks 12, 52, and 104
measure: Time to Onset of at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score
timeFrame: At the time of AD onset (up to Week 104)
measure: Percentage of Participants with at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Weeks 12, 52, and 104
timeFrame: At Weeks 12, 52, and 104
measure: Time to Onset of at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score
timeFrame: At the time of AD onset (up to Week 104)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Children and Adolescents, Clinical Trial Unit, Park Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Samuli Rautava, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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