Abstract
This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.
Highlights
Breastfeeding is the preferred source of nutrition for infants and has been proven to provide a range of short-term and long-term benefits for the child’s nervous, immune, metabolic and gastrointestinal system [1]
After introduction of the intervention formulae, the stool consistency values of infants consuming the experimental formula remained closer to that of the breastfed reference group with consistently and statistically lower values compared to infants in the Control group from 4 weeks of age2019, onwards
In line with previous findings [6], no relevant differences in parent- or investigator-reported incidence or severity of GI symptoms were observed between both formula groups, apart from a statistically lower incidence of infantile colic reported as an adverse event in the experimental group
Summary
Breastfeeding is the preferred source of nutrition for infants and has been proven to provide a range of short-term and long-term benefits for the child’s nervous, immune, metabolic and gastrointestinal system [1]. The presence of a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1) in (non-fermented) infant formula was proven to have beneficial effects on stool consistency and frequency, gut microbiota and immune function [12,13,14,15,16]. Combining this specific prebiotic mixture with different dosages of fermented infant formula (using the bacterial strains BbC50 and St065) did not raise any safety concerns in healthy, term infants [17]. A group of fully breastfed infants was included
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