Yu Renqiang, Ma Yizhe, Luo Zichen, Qi Ce, Xie Anni, Jiang Yifan, Zhu Baoli, Sun Jin
Department of Neonatology, Wuxi Maternity and Child Health Care Hospital, Women's Hospital of Jiangnan University, Wuxi, China.
Department of Pediatric, Jiangyin People's Hospital of Nantong University, Wuxi, China.
Front Microbiol. 2023 Oct 5;14:1267448. doi: 10.3389/fmicb.2023.1267448. eCollection 2023.
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.
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.
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.
https://www.chictr.org.cn/, identifier [ChiCTR2300075611].
随着城市化的快速发展，特应性皮炎（AD）的发病率迅速上升；然而，由于常用疗法只能缓解症状，AD的治疗选择仍然匮乏。FN041是从人母乳中分离出的一种特定菌株，其对AD的保护潜力已得到证实。本研究旨在评估孕妇在妊娠晚期和哺乳期食用FN041对预防婴儿AD的疗效。
首先，将对340名有AD高风险婴儿的孕妇进行一项随机、双盲、安慰剂对照干预研究。这些受试者将被随机分为四组，分别给予不同剂量的FN041（1×10、5×10和1×10 CFU/d）以及安慰剂。将分析孕妇使用FN041预防婴儿AD的安全性和有效性，并确定FN041的最有效剂量。随后，将对500名有AD高风险婴儿的孕妇进行一项多中心队列研究，以促进FN041在孕妇中的应用。这些受试者将在妊娠晚期和哺乳期的第一阶段确定的最佳剂量下服用FN041，并对其婴儿的AD发病情况进行分析。招募工作于2022年10月开始。
主要结局是孕妇在妊娠晚期和哺乳期食用FN041后24个月时AD的累积发病率，次要结局是口服补充后FN041从母亲肠道转移到母乳然后再到婴儿肠道的效率。本研究将证明从母乳中分离出的可食用益生菌在预防或治疗婴儿AD方面的疗效。因此，我们为孕妇预防性使用特定益生菌提供基于人群的建议。了解母乳来源益生菌菌株的潜在机制可促进其在预防与肠道微生物群失衡和免疫紊乱相关的婴儿疾病中的应用。
