NCT04662619

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-18
• Primary completion: 2023-12-07
• Completion: 2024-11-19
• First posted: 2020-12-10
• Last updated: 2024-12-16

Locations

1 site across 1 country: Finland