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

Renqiang Yu; Yizhe Ma; Zichen Luo; Ce Qi; Anni Xie; Yifan Jiang; Baoli Zhu; Jin Sun

doi:10.3389/fmicb.2023.1267448

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

Front Microbiol. 2023 Oct 5:14:1267448. doi: 10.3389/fmicb.2023.1267448. eCollection 2023.

Authors

Renqiang Yu¹, Yizhe Ma², Zichen Luo¹, Ce Qi³, Anni Xie¹, Yifan Jiang⁴, Baoli Zhu¹, Jin Sun³

Affiliations

¹ Department of Neonatology, Wuxi Maternity and Child Health Care Hospital, Women's Hospital of Jiangnan University, Wuxi, China.
² Department of Pediatric, Jiangyin People's Hospital of Nantong University, Wuxi, China.
³ Institute of Nutrition and Health, Qingdao University, Qingdao, China.
⁴ School of Medicine, Nantong University, Nantong, China.

Abstract

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. Limosilactobacillus reuteri (L. reuteri), 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 L. reuteri 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 L. reuteri FN041 (1 × 10⁹, 5 × 10⁹, and 1 × 10¹⁰ CFU/d) along with a placebo. The safety and efficacy of maternal use of L. reuteri FN041 for preventing infantile AD will be analyzed, and the most efficient dosage of L. reuteri 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 L. reuteri FN041. These subjects will be administered L. reuteri 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 L. reuteri FN041 during late pregnancy and lactation, whereas the secondary outcome is the efficiency of L. reuteri 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].

Keywords: Limosilactobacillus reuteri; atopic dermatitis; breast milk; infant; microbiota; probiotics.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work is supported by the Jiangsu Provincial Department of Science and Technology (No. BE2022698), the Wuxi Science and Technology Bureau (No. Y20222003), the Wuxi Municipal Medical Innovation Team (No. CXTD2021013), and the Wuxi Commission of Health and Family Planning (Nos. SW202201 and FYKY202109).