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

Primary Purpose

Healthy

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
B. infantis
Lactose Placebo
Sponsored by
Johnson & Johnson Consumer Inc. (J&JCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

undefined - 14 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HUS Children and Adolescents, Clinical Trial Unit, Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

B. infantis

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of Participants with Atopic Dermatitis (AD) through 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.

Secondary Outcome Measures

Percentage of Infants with Adverse Events Through 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.
Number of Participants with Atopic Dermatitis (AD) Through 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.
Time to Onset of AD Through Weeks 52 and 104
Time to onset of AD through Weeks 52 and 104 will be reported.
Percentage of Infants with B. infantis Gut Colonization at Week 12
Percentage of infants with B. infantis gut colonization at Week 12 will be reported.
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
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.
AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Time of AD Onset and at 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.

Full Information

First Posted
November 26, 2020
Last Updated
October 18, 2023
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Collaborators
Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)
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1. Study Identification

Unique Protocol Identification Number
NCT04662619
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Collaborators
Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B. infantis
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A once-daily oral feeding of lactose placebo will be provided to infants for 12 weeks.
Intervention Type
Other
Intervention Name(s)
B. infantis
Other Intervention Name(s)
Evivo
Intervention Description
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Lactose Placebo
Intervention Description
Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Number of Participants with Atopic Dermatitis (AD) through Week 52
Description
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.
Time Frame
Up to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104
Description
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.
Time Frame
Up to Weeks 12, 52 and 104
Title
Number of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104
Description
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.
Time Frame
Up to Weeks 24 and 104
Title
Time to Onset of AD Through Weeks 52 and 104
Description
Time to onset of AD through Weeks 52 and 104 will be reported.
Time Frame
Up to Weeks 52 and 104
Title
Percentage of Infants with B. infantis Gut Colonization at Week 12
Description
Percentage of infants with B. infantis gut colonization at Week 12 will be reported.
Time Frame
Week 12
Title
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
Description
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.
Time Frame
At the time of AD onset (up to Week 104), Weeks 12, 52, and 104
Title
AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Time of AD Onset and at Weeks 12, 52, and 104
Description
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.
Time Frame
At the time of AD onset (up to Week 104), Weeks 12, 52, and 104

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuli Rautava, M.D., Ph.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS Children and Adolescents, Clinical Trial Unit, Park Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
http://yoda.yale.edu
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A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis

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