BACKGROUND: Effects of probiotics on the immunological composition of breast milk have been investigated in a few previous studies. OBJECTIVES: The aims of this study were to determine the effects of synbiotic (probiotic plus prebiotic) supplementation on immunoglobulin A (IgA), transforming growth factor β1 (TGF-β1), and transforming growth factor β2 (TGF-β2) levels of breast milk and on diarrhea incidence in infants. METHODS: In this randomized, double-blind, and placebo-controlled trial, we recruited 80 lactating mothers who were exclusively breastfeeding their 3-month-old infants. We randomly divided the mothers into 2 groups to receive a daily synbiotic supplement (n = 40) or a placebo (n = 40) for 30 days. Demographic and clinical data (ie, health status) were obtained through an interview. The IgA levels of breast milk were detected by nephelometry, and the levels of TGF-β1 and TGF-β2 were measured using a commercial Platinum ELISA kit. RESULTS: The breast milk IgA increased significantly from 0.41 ± 0.09 to 0.48 ± 0.15 g/L in the supplemented group (P = .018), while in the placebo group, no significant changes were observed. Although the breast milk TGF-β1 levels did not change significantly, the TGF-β2 levels of breast milk increased significantly from 270 ± 37.8 to 382 ± 43.7 pg/mL in the supplemented group (P = .043). Also, the incidence of diarrhea in infants decreased significantly in the supplemented group while no significant changes were observed in the placebo group after the experimental period. CONCLUSION:Synbiotic supplementation may have positive effects on the immune composition of breast milk and the reduction of diarrhea incidence in infants.
RCT Entities:
BACKGROUND: Effects of probiotics on the immunological composition of breast milk have been investigated in a few previous studies. OBJECTIVES: The aims of this study were to determine the effects of synbiotic (probiotic plus prebiotic) supplementation on immunoglobulin A (IgA), transforming growth factor β1 (TGF-β1), and transforming growth factor β2 (TGF-β2) levels of breast milk and on diarrhea incidence in infants. METHODS: In this randomized, double-blind, and placebo-controlled trial, we recruited 80 lactating mothers who were exclusively breastfeeding their 3-month-old infants. We randomly divided the mothers into 2 groups to receive a daily synbiotic supplement (n = 40) or a placebo (n = 40) for 30 days. Demographic and clinical data (ie, health status) were obtained through an interview. The IgA levels of breast milk were detected by nephelometry, and the levels of TGF-β1 and TGF-β2 were measured using a commercial Platinum ELISA kit. RESULTS: The breast milk IgA increased significantly from 0.41 ± 0.09 to 0.48 ± 0.15 g/L in the supplemented group (P = .018), while in the placebo group, no significant changes were observed. Although the breast milk TGF-β1 levels did not change significantly, the TGF-β2 levels of breast milk increased significantly from 270 ± 37.8 to 382 ± 43.7 pg/mL in the supplemented group (P = .043). Also, the incidence of diarrhea in infants decreased significantly in the supplemented group while no significant changes were observed in the placebo group after the experimental period. CONCLUSION: Synbiotic supplementation may have positive effects on the immune composition of breast milk and the reduction of diarrhea incidence in infants.
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