Abstract

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.

Highlights

  • IntroductionMastitis is defined as “an inflammatory condition of the breast, which may or may not be accompanied by infection” [1], and it is considered to be one of the reasons to stop breastfeeding [2,3,4]

  • There were no differences in reported GI symptoms and stool characteristics between the probiotic and placebo group. This present study investigated the potential effect of oral administration of the probiotic L. salivarius PS2 during late pregnancy and early lactation on the prevention of mastitis incidence in lactating women

  • Fernández et al [20] investigated the efficacy of the same probiotic strain L. salivarius PS2 during the last 10 weeks of pregnancy in women with previous history of lactational mastitis

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Summary

Introduction

Mastitis is defined as “an inflammatory condition of the breast, which may or may not be accompanied by infection” [1], and it is considered to be one of the reasons to stop breastfeeding [2,3,4]. The worldwide reported mastitis incidence varies, but it is estimated to generally affect between 10% and 33% of lactating women [1]. A recent review indicated that approximately one out of four breastfeeding women has at least one episode of mastitis during the first. 26 weeks postpartum [5]. This wide variation among studies is most likely due to lack of a standard medical definition and well-defined diagnostic criteria. A generally accepted diagnosis is the assessment of clinical symptoms consisting of flu-like symptoms, breast

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