<i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain <i>Ligilactobacillus salivarius</i> PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter,...

Full description

Bibliographic Details
Main Authors: Esther Jiménez, Susana Manzano, Dietmar Schlembach, Krzysztof Arciszewski, Rocio Martin, Kaouther Ben Amor, Mieke Roelofs, Jan Knol, Juan Miguel Rodríguez, Michael Abou-Dakn, PREMIUM Study Group
Format: Article
Language:English
Published: MDPI AG 2021-09-01
Series:Microorganisms
Subjects:
Online Access:https://www.mdpi.com/2076-2607/9/9/1933
_version_ 1797518082709651456
author Esther Jiménez
Susana Manzano
Dietmar Schlembach
Krzysztof Arciszewski
Rocio Martin
Kaouther Ben Amor
Mieke Roelofs
Jan Knol
Juan Miguel Rodríguez
Michael Abou-Dakn
PREMIUM Study Group
author_facet Esther Jiménez
Susana Manzano
Dietmar Schlembach
Krzysztof Arciszewski
Rocio Martin
Kaouther Ben Amor
Mieke Roelofs
Jan Knol
Juan Miguel Rodríguez
Michael Abou-Dakn
PREMIUM Study Group
author_sort Esther Jiménez
collection DOAJ
description Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain <i>Ligilactobacillus salivarius</i> 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 (<i>p</i> = 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; <i>p</i> = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of <i>L. salivarius</i> PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.
first_indexed 2024-03-10T07:25:11Z
format Article
id doaj.art-7a028226a50845058f5fc33803adad94
institution Directory Open Access Journal
issn 2076-2607
language English
last_indexed 2024-03-10T07:25:11Z
publishDate 2021-09-01
publisher MDPI AG
record_format Article
series Microorganisms
spelling doaj.art-7a028226a50845058f5fc33803adad942023-11-22T14:19:19ZengMDPI AGMicroorganisms2076-26072021-09-0199193310.3390/microorganisms9091933<i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled TrialEsther Jiménez0Susana Manzano1Dietmar Schlembach2Krzysztof Arciszewski3Rocio Martin4Kaouther Ben Amor5Mieke Roelofs6Jan Knol7Juan Miguel Rodríguez8Michael Abou-Dakn9PREMIUM Study GroupProbisearch SLU, 28760 Tres Cantos, SpainProbisearch SLU, 28760 Tres Cantos, SpainClinic for Obstetrics, Vivantes Hospital Group, Neukölln, 12351 Berlin, GermanyPoliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. K, 15-435 Białystok, PolandDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsDepartment of Nutrition and Food Science, Complutense University of Madrid, 28040 Madrid, SpainBerlin Center for Diabetes and Pregnancy, Department of Obstetrics and Gynecology, St. Joseph Hospital, 12101 Berlin, GermanyMastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain <i>Ligilactobacillus salivarius</i> 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 (<i>p</i> = 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; <i>p</i> = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of <i>L. salivarius</i> PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.https://www.mdpi.com/2076-2607/9/9/1933breastfeeding supportmastitispreventionprobiotics<i>Lactobacillus salivarius</i><i>Ligilactobacillus salivarius</i>
spellingShingle Esther Jiménez
Susana Manzano
Dietmar Schlembach
Krzysztof Arciszewski
Rocio Martin
Kaouther Ben Amor
Mieke Roelofs
Jan Knol
Juan Miguel Rodríguez
Michael Abou-Dakn
PREMIUM Study Group
<i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
Microorganisms
breastfeeding support
mastitis
prevention
probiotics
<i>Lactobacillus salivarius</i>
<i>Ligilactobacillus salivarius</i>
title <i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
title_full <i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
title_fullStr <i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
title_full_unstemmed <i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
title_short <i>Ligilactobacillus salivarius</i> PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial
title_sort i ligilactobacillus salivarius i ps2 supplementation during pregnancy and lactation prevents mastitis a randomised controlled trial
topic breastfeeding support
mastitis
prevention
probiotics
<i>Lactobacillus salivarius</i>
<i>Ligilactobacillus salivarius</i>
url https://www.mdpi.com/2076-2607/9/9/1933
work_keys_str_mv AT estherjimenez iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT susanamanzano iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT dietmarschlembach iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT krzysztofarciszewski iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT rociomartin iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT kaoutherbenamor iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT miekeroelofs iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT janknol iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT juanmiguelrodriguez iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT michaelaboudakn iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial
AT premiumstudygroup iligilactobacillussalivariusips2supplementationduringpregnancyandlactationpreventsmastitisarandomisedcontrolledtrial