Prebiotic effect during the first year of life in healthy infants fed formula containing GOS as the only prebiotic: a multicentre, randomised, double-blind and placebo-controlled trial

European Journal of Nutrition, Sep 2014

Purpose Currently, there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula. This study assesses whether the feeding of a galactooligosaccharides (GOS)-containing infant formula (0.44 g/dl of GOS) and the subsequent feeding of a GOS-containing follow-on formula (0.50 g/dl of GOS) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life. Methods A multicentre, randomised, double-blind and placebo-controlled trial was carried out on 365 healthy term infants enrolled before 8 weeks of age and randomly assigned to a formula with or without GOS, until 12 months of age. The incidence of infections and allergy manifestations, the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age, while faecal samples were collected up to 4 months for the measurement of secretory immunoglobulin A, short-chain fatty acids and microbiota. Results A prebiotic effect on the faecal analysis was observed at 4 months of life. The GOS group showed a lower faecal pH (P = 0.019), a lower decreasing trend in secretory immunoglobulin A (P = 0.078), lower butyric acid concentration (P = 0.040) and an increase in Bifidobacterium counts (P = 0.010). Changes in faecal characteristics involved greater frequency (P < 0.001) and softer consistency (P < 0.05). The incidence of infections or allergic manifestations during the first year of life was similar in both groups, with no statistical differences (P > 0.05). Conclusions The feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of changes in faecal composition and microbiota, and in faecal consistency and the frequency of defaecation. No changes in the incidence of infection or allergic manifestation during the first year of life were observed.

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Prebiotic effect during the first year of life in healthy infants fed formula containing GOS as the only prebiotic: a multicentre, randomised, double-blind and placebo-controlled trial

Carlos Sierra 0 1 2 3 4 5 6 7 8 9 Mara-Jose Bernal 0 1 2 3 4 5 6 7 8 9 Javier Blasco 0 1 2 3 4 5 6 7 8 9 Rosario Martnez 0 1 2 3 4 5 6 7 8 9 Jaime Dalmau 0 1 2 3 4 5 6 7 8 9 Inmaculada Ortun o 0 1 2 3 4 5 6 7 8 9 Beatriz Espn 0 1 2 3 4 5 6 7 8 9 Mara-Isabel Vasallo 0 1 2 3 4 5 6 7 8 9 David Gil 0 1 2 3 4 5 6 7 8 9 Mara-Luisa Vidal 0 1 2 3 4 5 6 7 8 9 Da maso Infante 0 1 2 3 4 5 6 7 8 9 Rosaura Leis 0 1 2 3 4 5 6 7 8 9 Jose Maldonado 0 1 2 3 4 5 6 7 8 9 Jose-Manuel Moreno 0 1 2 3 4 5 6 7 8 9 Enriqueta Rom an 0 1 2 3 4 5 6 7 8 9 M.-I. Vasallo 0 1 2 3 4 5 6 7 8 9 0 J. Dalmau Hospital La Fe , Avda. Pianista Martnez Carrasco, s/n, 46026 Valencia, Spain 1 M.-J. Bernal (&) R. Martnez I. Ortuno M.-L. Vidal Research and Development Department , Hero Spain S.A., Avda. Murcia 1, 30820 Alcantarilla, Murcia, Spain 2 C. Sierra J. Blasco Hospital Materno-Infantil , Avda. Arroyo de los A 3 E. Roman Hospital Puerta de Hierro , Calle Manuel de Falla, 1, 28222 Majadahonda, Madrid, Spain 4 J.-M. Moreno Hospital Doce de Octubre , Avda. de Cordoba, s/n, 28041 Madrid, Spain 5 J. Maldonado Hospital Virgen de las Nieves , Avda. de las Fuerzas Armadas, 2, 18014 Granada, Spain 6 R. Leis Hospital Clnico Universitario , Travesa de Choupana, s/n, 15706 Santiago de Compostela, Spain 7 D. Infante Hospital Vall d'Hebron , Passeig Vall d'Hebron, 119-129, 08035 Barcelona, Spain 8 D. Gil Hospital Virgen de la Arrixaca , Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia, Spain 9 B. Espn Hospital Virgen del Roco , Avda. Manuel Siurot, s/n, 41013 Sevilla, Spain Purpose Currently, there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula. This study assesses whether the feeding of a galactooligosaccharides (GOS)-containing infant formula (0.44 g/dl of GOS) and the subsequent feeding of a GOS-containing follow-on formula (0.50 g/dl of GOS) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life. Methods A multicentre, randomised, double-blind and placebo-controlled trial was carried out on 365 healthy term infants enrolled before 8 weeks of age and randomly assigned to a formula with or without GOS, until 12 months of age. The incidence of infections and allergy manifestations, the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age, while faecal samples were collected up to 4 months for the measurement of secretory immunoglobulin A, short-chain fatty acids and microbiota. Results A prebiotic effect on the faecal analysis was observed at 4 months of life. The GOS group showed a lower faecal pH (P = 0.019), a lower decreasing trend in secretory immunoglobulin A (P = 0.078), lower butyric acid concentration (P = 0.040) and an increase in Bifidobacterium counts (P = 0.010). Changes in faecal characteristics involved greater frequency (P 0.001) and softer consistency (P \ 0.05). The incidence of infections or allergic manifestations during the first year of life was similar in both groups, with no statistical differences (P [ 0.05). Conclusions The feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of - changes in faecal composition and microbiota, and in faecal consistency and the frequency of defaecation. No changes in the incidence of infection or allergic manifestation during the first year of life were observed. Human milk oligosaccharides (HMOs), a complex mixture of glycan compounds, have been associated with the prevention of intestinal diseases, which are partially mediated by the modulation of the intestinal microbial ecology and immunological homeostasis [1, 2]. Prebiotics are nondigestible carbohydrates similar to HMOs. Because HMOs include a high quantity of galactose, galactooligosaccharides (GOS) are often the predominant prebiotic oligosaccharides used to supplement infant formulas. The prebiotic effect is defined as the selective stimulation of growth and/or activity(ies) of one or a limited number of microbial genus(era)/species in the gut microbiota that confer(s) health benefits to the host [3]. The main health benefits that intestinal microbiota confer are an improvement in faeces quality (pH, short-chain fatty acid content, frequency and consistency), a reduction in the risk of gastrointestinal infections, improved general well-being and a reduced incidence of allergic symptoms such as atopic eczema [3]. Infant formulas with added prebiotics are also associated with beneficial effects, but few studies have demonstrated an improvement in clinical outcomes such as infections and allergic manifestations [48]. Consequently, recent systematic reviews have concluded that further evidence is needed in order to recommend or not the routine addition of prebiotics to infant formulas to prevent infections [9] and allergy [9, 10]. The inclusion of GOS in infant formulas is believed to lead to an (...truncated)


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Carlos Sierra, María-José Bernal, Javier Blasco, Rosario Martínez, Jaime Dalmau, Inmaculada Ortuño, Beatriz Espín, María-Isabel Vasallo, David Gil, María-Luisa Vidal, Dámaso Infante, Rosaura Leis, José Maldonado, José-Manuel Moreno, Enriqueta Román. Prebiotic effect during the first year of life in healthy infants fed formula containing GOS as the only prebiotic: a multicentre, randomised, double-blind and placebo-controlled trial, European Journal of Nutrition, 2015, pp. 89-99, Volume 54, Issue 1, DOI: 10.1007/s00394-014-0689-9