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Título :	Safety of a dual potential prebiotic system from Mexican agave "Metlin® and Metlos®", incorporated to an infant formula for term newborn babies: a randomized controlled trial.
Creador:	López Velázquez, Gabriel
Nivel de acceso:	Open access
Palabras clave :	Agave - México - recién nacido Estatura - efectos de drogas Peso Corporal - efectos de drogas Defecación - efectos de drogas Diarrea Infantil - inducido químicamente femenino Flatulencia - inducido químicamente Estudios de Seguimiento Fructanos - administración & dosificación Fructanos - efectos adversos Fructanos - aislamiento y purificación Enfermedades Gastrointestinales - inducido químicamente Trastornos del Crecimiento - inducido químicamente Humanos Alimentos Infantiles - efectos adversos recién nacido - Masculino Leche Humana Extractos Vegetales - administración & dosificación Extractos Vegetales - adversos efectos Extractos Vegetales - farmacología Prebióticos - efectos adversos Vómitos - inducido químicamente Aumento de Peso - efectos de drogas Agave - Mexico - Infant, Newborn Body Height - drug effects Body Weight - drug effects Defecation - drug effects Diarrhea, Infantile - chemically induced Female Flatulence - chemically induced Follow-Up Studies Fructans - administration & dosage Fructans - adverse effects Fructans - isolation & purification Gastrointestinal Diseases - chemically induced Growth Disorders - chemically induced Humans Infant Food - adverse effects Infant, Newborn Male Milk, Human Plant Extracts - administration & dosage Plant Extracts - adverse effects Plant Extracts - pharmacology Prebiotics - adverse effects Vomiting - chemically induced Weight Gain - drug effects Metlin y Metlos. Seguridad de los fructanos de agave. Niños. Metlin and Metlos. Agave fructans safety. Children.
Descripción :	Justificación. Las fórmulas infantiles se han suplementado con probióticos, prebióticos o simbióticos, a pesar de que continúan existiendo dudas acerca de la seguridad y eficacia de los mismos. El agave mexicano es una fuente de fructanos con características particulares y con potencial efecto prebió- tico. Material y métodos. Ensayo clínico controlado (RCT) realizado en 600 recién nacidos de término sanos (20 ± 7 días), aleatorizados a recibir una fórmula infantil estándar (control) o una fórmula adicionada con mezcla variable de prebióticos derivados del agave mexicano. Los desenlaces primarios fueron la frecuencia y consistencia de las evacuaciones, los datos de tolerancia gastrointestinal (distensión abdominal, flatulencia, regurgitaciones y vómito). Los desenlaces secundarios fueron la ganancia pondo-estatural y la frecuencia de eczema. Resultados. En el análisis de 66,120 días de seguimiento no se observaron diferencias en la frecuencia diaria de las evacuaciones (leche materna 3.8 ± 2.4 evacuaciones/día; Pro + Metlin + Metlos 3.6 ± 2.0; Pro + Metlin 3.6 ± 2; fórmula sólo con probióticos 3.4 ± 2.3 y sólo fórmula 3.4 ± 2.0; p NS). La consistencia de las evacuaciones fue similar entre los grupos de leche materna y quienes recibieron la mezcla de prebióticos. La frecuencia de manifestaciones gastrointestinales fueron significativamente menores en estos mismos grupos. Conclusiones. La adición de fructanos derivados del agave mexicano en las fórmulas infantiles 484 López-Velázquez G, et al. Randomized controlled trial of Metlin + Metlos in infant formula. Rev Invest Clin 2013; 65 (6): 483-490 The evidence-based findings, reported in this paper were that prebiotic supplementation of infant formula: • Has no adverse effects on growth or adverse effects in healthy term infants. • Has the potential to reduce fecal pH. • Has the potential to increase stool frequency and soften stools, and • Increase the stool colony counts of bifidobacteria or lactobacilli. The Mexican Agave plant (Tequilana Weber Blue Variety) is an interesting source of fructans (non inulin-like), which are formed by a complex mix of FOS with a DP between 3 to 29, containing principally β (2 → 1) linkages, but also β (2 → 6) and branch moieties.30,31 Indeed, it had been demonstrated the bifidogenic and physiologic effects of these fructans in vitro and in animal models.31,32 Considering this evidence, we conducted an RCT in order evaluate the safety of “Metlin® and Metlos®”, a dual fructan system from Mexican agave, incorporated to an infant formula for term Mexican newborn babies. MATERIAL AND METHODS Randomized double blind clinical controlled trial (RDBCT), approved by Research Ethical Committee of the Instituto Nacional de Pediatría (INP), México, conducted in 600 term babies, 20 ± 7 days old at study admission, any gender, weight of 2,490 g or more at born in apparently good health, without medical history of maternal pathologies during pregnancy. The sample size was calculated, considering the primary outcomes, an α error of 0.05, a β error of 0.10 and a 20% of attrition. In order to be enrolled in the study, Mexican women at ≈ 30 weeks of gestation were invited to assist to INP after their children were born. Those women were regular patients of medical centers at the south part of Mexico City. Infants were eligible for the study if they met the following criteria: • The infant was clinically healthy. • The infant was term-born. • Age ≤ 27 days. • Weight ≥ 2,490 g. BACKGROUND Infant formulae are increasingly being supplemented with probiotics, prebiotics, or symbiotic despite uncertainties regarding their efficacy.1-4 In 2004 a position papers published by the Committee on Nutrition of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition, commented on the addition of prebiotic oligosaccharides to infant and follow-on formulae.5 On the basis of evidence obtained in a search up to January 2004, the Committee concluded that only limited studies have evaluated the effects of the addition of prebiotic substances to dietetic products for infants. The Committee stated that although the administration of prebiotic oligosaccharides has the potential to increase the total number of bifidobacteria in feces and may also soften stools; there was until that moment no published evidence of any clinical benefits of adding prebiotic oligosaccharides to dietetic products for infants. Of note, according to the Commission Directive 2006/141/ EC of 22 December 2006 on infant formulae and follow-on formulae, fructooligosaccharides (FOS) and galactooligosaccharides (GOS) may be voluntarily added to infant formulae if their content does not exceed 0.8 g/100 mL. In 2010 the same Committee carried out a systematic review of randomized controlled trials (RCT) according to the guidelines from the Cochrane Collaboration. Only those studies that compared the use of infant formula or follow-on formula supplemented with prebiotics during the manufacturing process were included.6 Twenty-three publications were identified for analysis.7-29 All of the studies were carried out in healthy term infants. The studies varied in the types of prebiotics used. The most commonly studied prebiotic was a 9:1 mixture of short-chain galactooligosaccharides (scGOS) and long-chain fructooligosaccharides (lcFOS). Other prebiotics studied were GOS, acidic oligosaccharides (AOS), GOS/ FOS/AOS, oligofructose plus inulin, and polydextrose (PDX) plus GOS (with or without lactulose). The doses of prebiotics ranged from 0.15-to 0.8-g/100 mL, and the duration of the intervention ranged from 2 weeks to 6 months. All but 2 RCT (which used follow-on formula) reported the prebiotic supplementation of a standard infant formula. es segura y bien tolerada por los recién nacidos sanos mexicanos. Rationale. Infant formulae are being supplemented with probiotics, prebiotics, or symbiotic despite uncertainties regarding their efficacy. Mexican agave is an interesting source of fructans with particular features and with potential prebiotic effects. Material and methods. RCT in 600 healthy term babies (20 ± 7 days), allocated to receive standard infant formula (control) or infant formula added with a dual prebiotic system "Metlin® and Metlos®", from Mexican agave. Primary outcomes include stools frequency, stools consistency, gastrointestinal intolerance (frequency of abdominal distension, flatulency, regurgitations, vomiting). Secondary outcomes inelude changes on weight and height along the study and frequency of dermatologic problems (eczema). Results. In 66,120 days of total follow-up, there were no differences on the frequency of stools passage (Human Milk: 3.8 ± 2.4 evacuations per day; Pro + Metlin + Metlos 3.6 ± 2.0; Pro + Metlin 3.6 ± 2; only Pro 3.4 ± 2.3, only formula 3.4 ± 2.0; p NS). Consistency of stools was similar between human milk and prebiotics supplemented groups. Also the frequency of gastrointestinal symptoms was significantly low between these groups. Conclusions. Fructans derivate from agave and added to infant formula are safe and well tolerated by Mexican healthy term babies.
Colaborador(es) u otros Autores:	Díaz-García Luisa Anzo Anahi Parra-Ortiz Minerva Llamosas-Gallardo Beatriz Ortiz-Hernández Ana Alejandra Mancilla-Ramírez Javier Cruz-Rubio José Manuel Gutiérrez-Castrellón Pedro
Fecha de publicación :	2013
Tipo de publicación:	Artículo
Formato:	pdf
Fuente:	Revista de Investigación Clínica 65(6):483 - 490
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2786
Idioma:	eng
Aparece en las colecciones:	Artículos

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