Clinical Trial ARTICLE
Effects of Probiotic Supplementation on TGF-β1, TGF-β2, and IgA Levels in the Milk of Japanese Women: An Open-label Pilot Study
- 1Bean Stalk Snow CO., Ltd.(Japan), Japan
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-β (TGF-β) 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 one, 2, and 3 months postpartum, and TGF-β1, TGF-β2, 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-β1 and β2 were not affected by lactation periods, and showed different patterns over time between the two groups. TGF-β1, TGF-β1, and IgA levels were significantly correlated at baseline (respectively p < 0.05). However, the correlation between TGF-β1 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-β 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.
Keywords: TGF-β, IgA, cytokine, Probiotics, human milk
Received: 19 Dec 2018;
Accepted: 29 Jul 2019.
Edited by:Kazim Sahin, Firat University, Turkey
Reviewed by:Sergio Davinelli, University of Molise, Italy
Ger Rijkers, University College Roosevelt, Netherlands
Copyright: © 2019 Takahashi, Fukudome, Ueno, Watanabe-Matsuhashi, Nakano and Kobayasi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Mr. Tomoki Takahashi, Bean Stalk Snow CO., Ltd.(Japan), Tokyo, Japan, firstname.lastname@example.org