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.
*University Children's Hospital, Zurich, Switzerland
†Department of Paediatrics, University of Pecs, Hungary
‡University Children's Hospital, Zagreb, Croatia
§Escuela Universitaria de Ciencias de la Salud, Universidad de Zaragoza, Spain
||Leeds General Infirmary, UK
¶Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Israel
#Department of Paediatrics, Medical University of Warsaw, Poland
**Jeanne de Flandre Children's Hospital, Lille University Faculty of Medicine, France
††Erasmus MC/Sophia Children's Hospital, Rotterdam, The Netherlands
‡‡Department of Paediatrics, Diakonieklinikum, Germany.
1 Committee Chair.
2 Committee Secretary.
Received 8 August, 2010
Accepted 8 August, 2010
Address correspondence and reprint requests to Hania Szajewska, MD, Department of Paediatrics, Medical University of Warsaw, 01-184 Warsaw, Dzialdowska 1, Poland (e-mail: firstname.lastname@example.org).
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The authors report no conflicts of interest other than that reported on the ESPGHAN Web site.