The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830 healthy term infants, without a first-degree family history of allergic disease, of mothers who indicated to give only formula feeding were randomised either to receive a standard non-hydrolysed cows' milk-based formula to which a mixture of specific oligosaccharides was added (prebiotics group (PG)), or to receive a similar formula without oligosaccharides (control group (CG)). A separate reference group consisted of 300 breast-fed infants. The primary outcome was the number of fever episodes prospectively documented by the parents. There was no difference in the number of fever episodes between the PG (median value 1·19; 25th -75th percentile 0·09-2·34) and CG (1·16; 25th -75th percentile 0·06-2·38). The median number of fever episodes in the separate breast-feeding reference group was 1·24 (25th -75th percentile 0·51-3·45). There was no effect of adding specific prebiotics to standard formula feeding in reducing the number of fever episodes in the present study. Key words: Infection: Infants: OligosaccharidesBreast-feeding is universally recommended as the optimal feeding for infants in the first 6 months of life (1,2) . There is clear evidence for health benefits for both mother and child. Special attention has been given to the effect regarding infections in young children (3 -5) . The protective effect of breastfeeding against infectious diseases is assumed to be provided by specific (antibody-dependent) and non-specific factors such as oligosaccharides, proteins, glycoproteins and fats. Many efforts have been made to make the composition of formula (e.g. proteins and fats) as close as possible to breast milk (6,7) .Human milk oligosaccharides, after lactose and lipids, represent the third largest solid component in breast milk, and contribute to immune modulation and infection prevention (8,9) . They exert prebiotic function by acting as soluble analogues to epithelial receptors for specific microbes, and this prevents their adhesion to the intestinal wall (10,11) . Further, they enhance mucosal barrier function with a direct effect on intestinal maturation and trophic effects on the intestinal mucosa through their fermentation products (12,13) ; lower the pH in the colon through the fermentation products (10,14) ; and interact directly with the cells of the immune system (15) .Thus, breast milk oligosaccharides are powerful candidates to be key components of human milk contributing to its protective effect against infections in infants. Clinical data about the effect of oligosaccharide supplementation to formula feeding on infections in young healthy children are scarce. Recently, two studies have been published pointing to a reduction of infections in the early life of infants who had an increased risk ...

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