Infant formulae are increasingly supplemented with probiotics, prebiotics, or synbiotics despite uncertainties regarding their efficacy. The present article, developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition, systematically reviews published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and/or prebiotics compared with unsupplemented formulae. Studies in which probiotics/prebiotics were not administered during the manufacturing process, but thereafter, for example in capsules, the contents of which were supplemented to infant formula or feeds, were excluded.On the basis of this review, available scientific data suggest that the administration of currently evaluated probiotic-and/or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects. The safety and clinical effects of 1 product should not be extrapolated to other products. At present, there is insufficient data to recommend the routine use of probiotic-and/or prebiotic-supplemented formulae. The Committee considers that the supplementation of formula with probiotics and/or prebiotics is an important field of research. There is a need in this field for well-designed and carefully conducted randomised controlled trials, with relevant inclusion/exclusion criteria and adequate sample sizes. These studies should use validated clinical outcome measures to assess the effects of probiotic and/or prebiotic supplementation of formulae. Such trials should also define the optimal doses and intake durations, as well as provide more information about the long-term safety of probiotics and/or prebiotics. Because most of the trials were company funded, independent trials, preferentially financed jointly by national/governmental/European Union bodies and other international organisations, would be desirable.

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Keywords Bifidobacteriaceae, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus paracasei, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus salivarius, Streptococcus thermophilus, anthropometric parameters, article, artificial milk, bacterial strain, body height, bronchopneumonia, child growth, colic, defecation habit, diarrhea, eczema, feeding, food safety, fructose oligosaccharide, galactose oligosaccharide, head circumference, human, infant feeding, infant nutrition, inulin, loose feces, microbiota, modification, oligosaccharide, paediatric nutrition, prebiotic agent, prebiotic supplementation, prick test, priority journal, probiotic agent, probiotic supplementation, randomized controlled trial (topic), safety, supplementation, synbiotic agent, synbiotic supplementation, systematic review, systematic review (topic), weight gain
Persistent URL dx.doi.org/10.1097/MPG.0b013e3181fb9e80, hdl.handle.net/1765/23514
Citation
Braegger, C., Chmielewska, A., Decsi, T., Kolacek, S., Mihatsch, W., Moreno, L., … van Goudoever, J.B.. (2011). Supplementation of infant formula with probiotics and/or prebiotics: A systematic review and comment by the ESPGHAN committee on nutrition. Journal of Pediatric Gastroenterology and Nutrition, 52(2), 238–250. doi:10.1097/MPG.0b013e3181fb9e80