Probiotic Supplementation and Human Milk Cytokine Profiles in Japanese Women: A Retrospective Study from an Open-Label Pilot Study.

The benefits of probiotic supplementation to lactating mothers on human milk cytokines are inconclusive. Thus, we performed a comprehensive open-label pilot trial analysis of 27 human milk cytokines in lactating women with allergies (one to three months postpartum) to determine the effect of supplementation with a mixture of new probiotic strains. Participants voluntarily joined the probiotic (n = 41) or no supplementation control (n = 19) groups. The probiotic group took three probiotic tablets (Lactobacillus casei LC5, Bifidobacterium longum BG7, and Bacillus coagulans SANK70258) daily for one to three months postpartum. Milk samples were collected at one, two, and three months postpartum, and cytokine levels were measured using multiplex assays. The effects were analyzed using multivariate regression models. Eleven cytokines showed a positive rate of over 50% in the milk samples throughout testing in both groups. The positive rates of IL-1 receptor antagonist and IL-7 changed significantly with lactation progression in logistic regression models after adjusting for time and supplementation, whereas rates of other cytokines showed no significant differences. The lactational change patterns of IL-10 concentrations differed significantly between the two groups. A short-term supplementation of probiotics affects human milk cytokine levels in lactating women with a possible placebo effect still existing. Future placebo-controlled studies are needed to support these results, based on the estimated sample sizes in this study.

Maternal Health and Nutrition Status, Human Milk Composition, and Growth and Development of Infants and Children: A Prospective Japanese Human Milk Study Protocol.

It is unknown whether maternal health and nutrition are related to human milk composition or growth and development of infants and children. Here, we describe a protocol for a prospective five-year cohort study to clarify (i) how maternal health and nutrition, socioeconomic factors, and lifestyles affect human milk composition, and (ii) whether these are associated with growth and development of infants and children. In our study, we recruited 1210 Japanese mothers with singleton pregnancies from 73 obstetrics clinics and hospitals across Japan, between 2014 and 2019. We will measure the following: health information regarding maternal-child dyads using a self-administered questionnaire, maternal nutrition during breastfeeding using a Brief self-administrated Diet History Questionnaire, the development of infants and children using the Kinder Infant Development Scale, and the stress related to child rearing using the Mother's Child Care Stress Scale. Simultaneously, we will collect human milk every 2 months during the first year after birth to measure its composition and levels of macronutrients. This study will generate useful data to investigate whether health status, nutritional status, lifestyle, and socioeconomic factors affect human milk composition and the growth and development of infants and children.

Effects of Probiotic Supplementation on TGF-ß1, TGF-ß2, and IgA Levels in the Milk of Japanese Women: An Open-Label Pilot Study.

Background: Dietary probiotics supplementation in lactating mothers may help prevent allergic disease in infants. However, owing to a lack of consistency in nutritional and safety outcomes associated with probiotics, this topic remains controversial. Methods: In this open-label pilot trial conducted between April 2013 and December 2013, we evaluated the safety of probiotic supplementation with 5 × 109 CFU of Lactobacillus casei LC5, 5 × 109 CFU of Bifidobacterium longum BG7, and 2 × 108 CFU of Bacillus coagulans SANK70258 in lactating women who exhibited allergies for 2 months (1-3 months postpartum); we also evaluated the effects of probiotic supplementation on transforming growth factor-ß (TGF-ß) and immunoglobulin A (IgA) levels in human milk. Participants self-selected to join the probiotic (n = 41; age [median (interquartile range [IQR]), y] 33 [27-39], body mass index [BMI] [median (IQR), kg/m2] 21.8 [19.5-22.8]) or no supplementation control group (n = 19; age [median (IQR), y] 33 [23-43], BMI [median (IQR), kg/m2) 19.6 [18.4-22.1]). Probiotics (three tablets) received were taken as daily supplements. Milk samples were collected at 1, 2, and 3 months postpartum, and TGF-ß1, TGF-ß2, and IgA levels were measured. Results: No adverse effects were observed in the probiotic group, according to the self-recorded diary during the study period. Milk IgA decreased with increasing postpartum months in both groups. In contrast, TGF- ß1 and ß2 were not affected by lactation periods, and showed different patterns over time between the two groups. TGF-ß1, TGF-ß1, and IgA levels were significantly correlated at baseline (respectively p < 0.05). However, the correlation between TGF-ß1 and IgA became non-significant by the end of the intervention (p = 0.063). Conclusion: Altogether, probiotic supplementation was tolerated with respect to no dropout and 91.5% adherence. Although probiotic supplementation might affect human milk TGF-ß levels, a positive effect of probiotic supplementation was not entirely supported. Future placebo-controlled studies are needed to further support the efficacy and safety of probiotic supplementation. Clinical Trial Registration: www.umin.ac.jp/ctr/, identifier: UMIN000036059.