Randomized, Double-Blind, Placebo-Controlled Study of Synbiotic Yogurt Effect on the Health of Children

Objective To assess the effects of daily consumption of a synbiotic yogurt drink on the health, growth, and quality of life of healthy children 12-48 months of age in out-of-home child care. Study design Healthy children attending child care centers were enrolled in a prospective, double-blind, placebo-controlled clinical trial. The intervention was a yogurt drink containing Streptococcus thermophilus, Lactobacillus bulgaricus, and Bifidobacterium animalis subspecies lactis (BB-12) (5 × 109 cfu/100 mL serving), and 1 g of inulin (synbiotic group) vs a similar nonsynbiotic-containing acidified milk drink (placebo group) once daily for 16 weeks. The end points were days of diarrhea, fever, vomiting, symptoms of upper respiratory tract infection, use of antibiotics, physician visits, child care absenteeism, parental work absenteeism, and quality of life (PedsQL 4.0; Mapi Research Trust, Lyon, France). Results Compared with placebo (n = 73), children receiving synbiotic (n = 76) had significantly fewer days of reported fever (1.85 vs 1.95, P < .05), significant improvement in social functioning (P < .035; pre-to-end intervention), and school functioning (P < .045; pre-to-mid intervention). More days with ≥3 loose/watery stools were reported in the synbiotic group (P < .05). Conclusions Daily supplementation of children's diet with yogurt containing probiotic bacteria BB-12 and inulin significantly reduced days of fever and improved social and school functioning. The increased frequency of bowel movements may be explained by an accelerating effect of BB-12 and inulin on intestinal transit. Further research on the possible benefits of synbiotics on children's health is advised. Trial registration ClinicalTrials.gov: NCT00653705. To assess the effects of daily consumption of a synbiotic yogurt drink on the health, growth, and quality of life of healthy children 12-48 months of age in out-of-home child care. Healthy children attending child care centers were enrolled in a prospective, double-blind, placebo-controlled clinical trial. The intervention was a yogurt drink containing Streptococcus thermophilus, Lactobacillus bulgaricus, and Bifidobacterium animalis subspecies lactis (BB-12) (5 × 109 cfu/100 mL serving), and 1 g of inulin (synbiotic group) vs a similar nonsynbiotic-containing acidified milk drink (placebo group) once daily for 16 weeks. The end points were days of diarrhea, fever, vomiting, symptoms of upper respiratory tract infection, use of antibiotics, physician visits, child care absenteeism, parental work absenteeism, and quality of life (PedsQL 4.0; Mapi Research Trust, Lyon, France). Compared with placebo (n = 73), children receiving synbiotic (n = 76) had significantly fewer days of reported fever (1.85 vs 1.95, P < .05), significant improvement in social functioning (P < .035; pre-to-end intervention), and school functioning (P < .045; pre-to-mid intervention). More days with ≥3 loose/watery stools were reported in the synbiotic group (P < .05). Daily supplementation of children's diet with yogurt containing probiotic bacteria BB-12 and inulin significantly reduced days of fever and improved social and school functioning. The increased frequency of bowel movements may be explained by an accelerating effect of BB-12 and inulin on intestinal transit. Further research on the possible benefits of synbiotics on children's health is advised.