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

February 27, 2024 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00290
        • HUS Children and Adolescents, Clinical Trial Unit, Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B. infantis
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
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks.
Other Names:
  • Evivo
Placebo Comparator: Placebo
A once-daily oral feeding of lactose placebo will be provided to infants for 12 weeks.
Other: Lactose Placebo
Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Atopic Dermatitis (AD) through Week 52
Time Frame: Up to Week 52
Number 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104
Time Frame: Up to Weeks 12, 52 and 104
The percentage of infants with AEs, serious adverse events (SAEs), AEs leading to discontinuation, and AEs related to the gastrointestinal system will be determined at Weeks 12, 52 and 104.
Up to Weeks 12, 52 and 104
Number of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104
Time Frame: Up to Weeks 24 and 104
Number of participants with AD through Week 24 and 104 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 Weeks 24 and 104
Time to Onset of AD Through Weeks 52 and 104
Time Frame: Up to Weeks 52 and 104
Time to onset of AD through Weeks 52 and 104 will be reported.
Up to Weeks 52 and 104
Percentage of Infants with B. infantis Gut Colonization at Week 12
Time Frame: Week 12
Percentage of infants with B. infantis gut colonization at Week 12 will be reported.
Week 12
Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score at Time of AD Onset and at Weeks 12, 52, and 104
Time Frame: At the time of AD onset (up to Week 104), Weeks 12, 52, and 104
Atopic Dermatitis (AD) severity based on the EASI score at time of AD onset and at Weeks 12, 52, and 104 will be reported. Physician rates severity of four parameters: erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Physician determines how much area is affected on a scale of 0 (none) to 6 (90 to 100%). A body region score is determined by multiplying the sum of the severity scores by the affected area score by a constant corresponding to the relative body surface area for that body region (20%, 30%, 20%, and 30%, respectively). The 4 body region scores are summed to yield the EASI score which ranges from 0 to 72, with a higher score indicating more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age.
At the time of AD onset (up to Week 104), Weeks 12, 52, and 104
AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Time of AD Onset and at Weeks 12, 52, and 104
Time Frame: At the time of AD onset (up to Week 104), Weeks 12, 52, and 104
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. Study Personnel will interview Caregivers at time of AD diagnosis and (only for participants with AD) at Weeks 12, 52, and 104 to rate seven symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness) using a 5-point scale of frequency of occurrence during the previous week (no days, 1-2 days, 3-4 days, 5-6 days, every day). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age.
At the time of AD onset (up to Week 104), Weeks 12, 52, and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Collaborators

Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)

Investigators

  • Principal Investigator: Samuli Rautava, M.D., Ph.D., Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

December 7, 2023

Study Completion (Estimated)

November 18, 2024

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCSNUT002443 (Other Identifier: Johnson & Johnson Consumer Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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