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Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial Neumer, Franka Urraca, Orenci Alonso, Joaquin Palencia, Jesús Varea, Vicente Theis, Stephan Guarner Aguilar, Francisco Institut Català de la Salut [Neumer F] BENEO-Institute, c/o BENEO GmbH, 67283 Obrigheim, Germany. [Urraca O] Hospital de Nens, 08009 Barcelona, Spain. [Alonso J] CAP Llefià, 08913 Badalona, Spain. [Palencia J] Equipo Pediátrico San Francisco, 28036 Madrid, Spain. [Varea V] Department of Gastroenterology, Hospital Sant Joan de Déu, 08017 Barcelona, Spain. [Guarner F] Unitat de Recerca en l’Aparell Digestiu, Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Prebiòtics Llet maternitzada Avaluació de resultats (Assistència sanitària) PHENOMENA AND PROCESSES::Physiological Phenomena::Diet, Food, and Nutrition::Beverages::Milk Substitutes::Infant Formula CHEMICALS AND DRUGS::Carbohydrates::Dietary Carbohydrates::Dietary Fiber::Prebiotics Other subheadings::Other subheadings::Other subheadings::/administration & dosage ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome FENÓMENOS Y PROCESOS::fenómenos fisiológicos::dieta, alimentación y nutrición::bebidas::sustitutivos de la leche::fórmulas infantiles COMPUESTOS QUÍMICOS Y DROGAS::hidratos de carbono::carbohidratos de la dieta::fibras de la dieta::prebióticos Otros calificadores::Otros calificadores::Otros calificadores::/administración & dosificación TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Eficàcia; Fórmula infantil; Prebiòtic Eficacia; Fórmula infantil; Prebiótico Efficacy; Infant formula; Prebiotic 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®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °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®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. The clinical study was part of the EARNEST project (EARly Nutrition programming-long term follow up of Efficacy and Safety Trials and integrated epidemiological, genetic, animal, consumer and economic research), an EU-funded integrated project within the 6th Framework Programme (FOOD-CT-2005-007036). Within this project, Laboratorios Ordesa, Barcelona, Spain and BENEO-Orafti, Tienen, Belgium contributed to the overall funding of the SYNERGY-1 study. 2022-01-12T17:56:09Z 2022-01-12T17:56:09Z 2021-04-13 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Neumer F, Urraca O, Alonso J, Palencia J, Varea V, Theis S, et al. Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial. Nutrients. 2021 Apr 13;13(4):1276. 2072-6643 https://hdl.handle.net/11351/6774 10.3390/nu13041276 33924514 https://doi.org/10.3390/nu13041276 http://hdl.handle.net/11351/6774 eng Nutrients;13(4) https://doi.org/10.3390/nu13041276 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf MDPI Scientia