Do prebiotics reduce the number of fever episodes in healthy children in their first year of life: a randomised controlled trial

Abstract

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 ...

Nutrition of the preterm infant

“…Studies in term infants with a family history of allergic symptoms have shown a reduction of infections and al- lergic symptoms. In a large European study in infants without a family history of allergy, we hardly found a difference in the incidence of infections in relation with the supplementation with pre-biotics [11,26]. Studies in preterm infants found a lower incidence of infections in infants receiving a combination of pre-biotics [19].…”

Prebiotics in infant formula

“…14 In a large randomized, double-blind, placebo-controlled trial performed in 830 healthy term infants in 7 centers in 5 West European countries, there was no effect of adding specific prebiotics to standard formula feeding in reducing the number of fever episodes. 49 On the contrary, other data state that infants fed a scGOS/lcFOS mixture were reported to have fewer episodes of physician-diagnosed overall and upper respiratory tract infections (P < 0.01), fever episodes (P < 0.00001), and fewer antibiotic prescriptions (P < 0.05) during the period of intervention and up to the age of 2 y. 38,50 In an open trial including 342 healthy infants comparing standard infant formula with a GOS/FOS enriched formula given during 6 months, at the age of 12 months the incidence of gastroenteritis was reduced (0.12 C 0.04 vs. 0.29 C 0.05 episodes/child/12 months; p D 0.015), the number of children with more than 3 episodes of gastroenteritis tended to be lower (17/60 vs. 29/65; p D 0.06) and the number of children with multiple antibiotic courses/year was lower (24/60 vs. 43/65; p D 0.004).…”

Supplementation of prebiotics in infant formula

“…Bruzzese et al 25 reported a lower incidence of gastroenteritis in the supplemented group. On the other hand, the study by van Stuijvenberg et al 26 found a non-significant difference in the number of fever episodes.…”