title: 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.
abstract: BACKGROUND
  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.
  
  
  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 include 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.
authors.forename: Gabriel
authors.initials: G
authors.lastname: López-Velázquez
authors.forename: Luisa
authors.initials: L
authors.lastname: Díaz-García
authors.forename: Anahi
authors.initials: A
authors.lastname: Anzo
authors.forename: Minerva
authors.initials: M
authors.lastname: Parra-Ortiz
authors.forename: Beatriz
authors.initials: B
authors.lastname: Llamosas-Gallardo
authors.forename: Ana Alejandra
authors.initials: AA
authors.lastname: Ortiz-Hernández
authors.forename: Javier
authors.initials: J
authors.lastname: Mancilla-Ramírez
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Cruz-Rubio
authors.forename: Pedro
authors.initials: P
authors.lastname: Gutiérrez-Castrellón
mesh_terms: D027882:Agave; D001827:Body Height / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003672:Defecation / Q000187:drug effects; D003968:Diarrhea, Infantile / Q000139:chemically induced; D005260:Female; D005414:Flatulence / Q000139:chemically induced; D005500:Follow-Up Studies; D005630:Fructans / Q000008:administration & dosage / Q000009:adverse effects* / Q000302:isolation & purification; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006130:Growth Disorders / Q000139:chemically induced*; D006801:Humans; D007225:Infant Food / Q000009:adverse effects*; D007231:Infant, Newborn; D008297:Male; D008895:Milk, Human; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology; D056692:Prebiotics / Q000009:adverse effects*; D014839:Vomiting / Q000139:chemically induced; D015430:Weight Gain / Q000187:drug effects
chemical_list: D005630:Fructans; D010936:Plant Extracts; D056692:Prebiotics