Supplementation of Infant Formula With Probiotics and/or Prebiotics: A Systematic Review and Comment by the ESPGHAN Committee on Nutrition

Abstract

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.

Comparison of formula‐fed infants with and without colic revealed significant differences in total bacteria, Enterobacteriaceae and faecal ammonia

“…In particular, probiotics and prebiotics have gained great interest in the field of infant nutrition after the discovery of indigestible oligosaccharides in human milk, which contribute to shape the intestinal microbiota of newborns. Thus, prebiotics and probiotics have been added to infant formulas to improve the gut health of infants with colic, in spite of doubts regarding their efficacy (15).…”

The basics of prescribing infant formulas

“…Adding them is optional, providing they do not exceed 0.8g/ 100 ml. 10,11 The motivation for adding probiotics to infant formula is that they might have a positive effect on digestion, with regard to the frequency and duration of gastrointestinal infections, including acute rotavirus gastroenteritis. They might reduce the risk of antibiotic-associated diarrhoea developing, as well as improve immunity.…”

Probiotics, Prebiotics and Synbiotics for Infant Feeding

“…Long-term benefit of prebiotics must be evaluated by confirmatory well-designed clinical research studies [167] and safety and efficacy of infant formula supplemented with prebiotics must be evaluated through at least two randomized control studies prior to its commercialization [168]. The Committee on Nutrition of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition reported that presently, there is insufficient data to recommend the routine use of probiotic-and/or prebiotic-supplemented formulae [169] and stressed upon the need to define the mechanisms, optimal doses and intake durations, as well as provide more information about the long-term safety of probiotics and/or prebiotics [169][170][171].…”