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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

NCT04662619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Lactose Placebo

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Samuli Rautava, M.D., Ph.D. · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2023-12-07
Completion
2024-11-19

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662619 on ClinicalTrials.gov