ena-STUDY-TUM-06-06-2017-16:55:56:208-584
Randomized controlled trial on the impact of early live intervention with bifidobacteria on the healthy infant fecal microbiota and metabolite profile
Background: Early life colonization of the intestinal tract is a dynamic process influenced by numerous factors. The impact of probiotic-supplemented infant formula on the composition and function of the infant gut microbiota is not well defined. Objective:To determine the effect of a bifidobacteria-containing formula on the healthy human intestinal microbiome during the first year of life.Design: Double-blinded, randomized and placebo-controlled study with newborn infants assigned to a standard whey-based formula containing a total of 10(8) cfu/g of Bifidobacterium bifidum, B. breve, B. longum, B. longum subsp. infantis (intervention), or to control formula without bifidobacteria (placebo). Breast-fed controls were included. Diversity and composition of fecal microbiota were determined by 16S rRNA gene amplicon sequencing and metabolite profiles were analysed by UHP-LC mass spectrometry over a period of two years. Results: One hundred six infants were randomized to the interventional (n=48) or placebo (n=49) group; 9 infants were solely breast-fed throughout the entire intervention period of 12 months. Infants exposed to bifidobacteria-supplemented formula showed decreased occurrence of Bacteroides and Blautia spp. associated  with changes in lipids and unknown metabolites at month 1. Microbiota and metabolite profiles converged during the intervention period and long-term colonization (24 months) of the supplemented Bifidobacterium strains was not detected. Significant differences in microbiota and metabolites were detected between infants fed by breast or formula (p<0.005) and between infants born by vaginal and caesarean birth (p<0.005). No significant differences were observed between infant feeding groups regarding growth, antibiotic uptake, or other health variables (p>0.05).Conclusions: The supplementation of bifidobacteria to infant diet can modulate the occurrence of specific bacteria and metabolites during early life with no detectable long-term effects.
Background: Early life colonization of the intestinal tract is a dynamic process influenced by numerous factors. The impact of probiotic-supplemented infant formula on the composition and function of the infant gut microbiota is not well defined. Objective:To determine the effect of a bifidobacteria-containing formula on the healthy human intestinal microbiome during the first year of life.Design: Double-blinded, randomized and placebo-controlled study with newborn infants assigned to a standard whey-based formula containing a total of 10(8) cfu/g of Bifidobacterium bifidum, B. breve, B. longum, B. longum subsp. infantis (intervention), or to control formula without bifidobacteria (placebo). Breast-fed controls were included. Diversity and composition of fecal microbiota were determined by 16S rRNA gene amplicon sequencing and metabolite profiles were analysed by UHP-LC mass spectrometry over a period of two years. Results: One hundred six infants were randomized to the interventional (n=48) or placebo (n=49) group; 9 infants were solely breast-fed throughout the entire intervention period of 12 months. Infants exposed to bifidobacteria-supplemented formula showed decreased occurrence of Bacteroides and Blautia spp. associated  with changes in lipids and unknown metabolites at month 1. Microbiota and metabolite profiles converged during the intervention period and long-term colonization (24 months) of the supplemented Bifidobacterium strains was not detected. Significant differences in microbiota and metabolites were detected between infants fed by breast or formula (p<0.005) and between infants born by vaginal and caesarean birth (p<0.005). No significant differences were observed between infant feeding groups regarding growth, antibiotic uptake, or other health variables (p>0.05).Conclusions: The supplementation of bifidobacteria to infant diet can modulate the occurrence of specific bacteria and metabolites during early life with no detectable long-term effects.