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Article

Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

1
Probisearch SLU, 28760 Tres Cantos, Spain
2
Department of Nutrition and Food Science, Complutense University of Madrid, 28040 Madrid, Spain
3
Clinic for Obstetrics, Vivantes Hospital Group, Neukölln, 12351 Berlin, Germany
4
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. K, 15-435 Białystok, Poland
5
Danone Nutricia Research, 3584 CT Utrecht, The Netherlands
6
Laboratory of Microbiology, Wageningen University, 6708 WE Wageningen, The Netherlands
7
Berlin Center for Diabetes and Pregnancy, Department of Obstetrics and Gynecology, St. Joseph Hospital, 12101 Berlin, Germany
*
Author to whom correspondence should be addressed.
Membership of the PREMIUM Study Group is provided in the Acknowledgments.
Academic Editors: Gaspar Pérez-Martínez and Christine Bäuerl
Microorganisms 2021, 9(9), 1933; https://doi.org/10.3390/microorganisms9091933
Received: 19 July 2021 / Revised: 2 September 2021 / Accepted: 7 September 2021 / Published: 11 September 2021
(This article belongs to the Special Issue Dialogue of Probiotics with the Host)
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. View Full-Text
Keywords: breastfeeding support; mastitis; prevention; probiotics; Lactobacillus salivarius; Ligilactobacillus salivarius; pregnancy; lactation; randomized controlled trial; nutritional interventions breastfeeding support; mastitis; prevention; probiotics; Lactobacillus salivarius; Ligilactobacillus salivarius; pregnancy; lactation; randomized controlled trial; nutritional interventions
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MDPI and ACS Style

Jiménez, E.; Manzano, S.; Schlembach, D.; Arciszewski, K.; Martin, R.; Ben Amor, K.; Roelofs, M.; Knol, J.; Rodríguez, J.M.; Abou-Dakn, M.; PREMIUM Study Group. Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial. Microorganisms 2021, 9, 1933. https://doi.org/10.3390/microorganisms9091933

AMA Style

Jiménez E, Manzano S, Schlembach D, Arciszewski K, Martin R, Ben Amor K, Roelofs M, Knol J, Rodríguez JM, Abou-Dakn M, PREMIUM Study Group. Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial. Microorganisms. 2021; 9(9):1933. https://doi.org/10.3390/microorganisms9091933

Chicago/Turabian Style

Jiménez, Esther, Susana Manzano, Dietmar Schlembach, Krzysztof Arciszewski, Rocio Martin, Kaouther Ben Amor, Mieke Roelofs, Jan Knol, Juan M. Rodríguez, Michael Abou-Dakn, and PREMIUM Study Group. 2021. "Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial" Microorganisms 9, no. 9: 1933. https://doi.org/10.3390/microorganisms9091933

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