Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial
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Neumer, F.; Urraca, O.; Alonso, J.; Palencia, J.; Varea, V.; Theis, S.; Rodriguez-Palmero, M.; Moreno-Muñoz, J.A.; Guarner, F.; Veereman, G.; et al. Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial. Nutrients 2021, 13, 1276. [https://doi.org/10.3390/nu13041276]
SponsorshipEuropean Commission FOOD-CT-2005-007036
The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti(R)Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 degrees C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti(R)Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.