CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 273 enrolled
Drug / intervention
B. infantis +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04662619
NCT04662619N/ACompleted
CompareCT.gov

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

Johnson & Johnson Consumer Inc. (J&JCI)·interventional·Posted Dec 10, 2020·Updated Dec 16, 2024

In Brief

A clinical study evaluating B. infantis and Lactose Placebo for Healthy. Completed, enrolled 273 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesFinland
CollaboratorsInfinant Health, Inc. (formerly known as Evolve BioSystems, Inc.)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 10, 2020
Enrollment StartDec 18, 2020
Primary CompletionDec 7, 2023
Study CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.6 years ago

Interventions

B. infantisother

Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks.

Lactose Placeboother

Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.