Maternal supplementation with FN041 for preventing infants with atopic dermatitis: study protocol for a randomized controlled trial.

Background: Atopic dermatitis (AD) has increased rapidly with rapid urbanization; however, the treatment options for AD are lacking because the commonly used therapies can only alleviate symptoms. FN041 is a specific strain isolated from human breast milk, and its protective potential against AD has been confirmed. This study aims to assess the efficacy of maternal consumption of FN041 during late pregnancy and lactation in preventing infantile AD.

Methods: First, a randomized, double-blind, placebo-controlled intervention study will be conducted on 340 pregnant females with babies at high risk for AD. These subjects will be randomly divided into four groups of different doses of FN041 (1 × 10, 5 × 10, and 1 × 10 CFU/d) along with a placebo. The safety and efficacy of maternal use of FN041 for preventing infantile AD will be analyzed, and the most efficient dosage of FN041 will be determined. Subsequently, a multicenter cohort study of 500 pregnant females with babies at high risk for AD will be conducted to promote the maternal application of FN041. These subjects will be administered FN041 at the optimal dose determined during the first stage of late pregnancy and lactation, and their babies will be analyzed for AD development. Recruitment was initiated in October 2022.

Discussion: The primary outcome is the cumulative incidence of AD at 24 months after maternal consumption of FN041 during late pregnancy and lactation, whereas the secondary outcome is the efficiency of FN041 transfer from the mother's gut to breast milk and then the infant's gut after oral supplementation. This study will demonstrate the efficacy of edible probiotics isolated from breast milk in preventing or treating AD in infants. Accordingly, we provide population-based advice for administering specific probiotics for the primary prevention of AD in pregnant females. Understanding the underlying mechanisms of probiotic strains derived from breast milk can promote their application in preventing infant diseases associated with intestinal microbiota imbalance and immune disorders.

Clinical Trial Registration: https://www.chictr.org.cn/, identifier [ChiCTR2300075611].