title: The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study.
abstract: BACKGROUND
  Constipation is a common disorder in children.
  
  
  OBJECTIVE
  The objective of this study is to assess the beneficial effects of a daily supplementation with Orafti®inulin-type fructans in 2-5 year old constipated children.
  
  
  METHODS
  Double-blind, randomised, placebo-controlled parallel group trial where constipated children received two doses of 2 g Orafti®inulin-type fructans (OF:IN) or placebo (maltodextrin) for 6 weeks. Primary outcome was stool consistency. Secondary outcomes were stool frequency and gastrointestinal symptoms.
  
  
  RESULTS
  Twenty-two children were included, 17 completed the study protocol (nine and eight for the control and the OF:IN group, respectively). Results showed that Orafti®inulin-type fructans supplemented children had softer stools (p = .003). The longitudinal analysis showed no significant changes in controls, whereas supplemented children increased their stool consistency from 2.2 to 2.6 on the modified Bristol scale for children (five items instead of seven) (p = .040).
  
  
  CONCLUSIONS
  Prebiotic inulin-type fructans supplementation improves stool consistency in constipated 2-5-year old children. Clinicaltrials.gov, with number NCT02863848.
authors.affiliation: a Neonatal Unit , Hospital Universitari Joan XXIII de Tarragona , Tarragona , Spain.|b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Closa-Monasterolo
authors.affiliation: b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.
authors.forename: Natalia
authors.initials: N
authors.lastname: Ferré
authors.affiliation: b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.|d Paediatrics Unit , Hospital Universitari Sant Joan de Reus , Reus , Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Castillejo-DeVillasante
authors.affiliation: a Neonatal Unit , Hospital Universitari Joan XXIII de Tarragona , Tarragona , Spain.|b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.
authors.forename: Veronica
authors.initials: V
authors.lastname: Luque
authors.affiliation: b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.
authors.forename: Mariona
authors.initials: M
authors.lastname: Gispert-Llaurado
authors.affiliation: b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Zaragoza-Jordana
authors.affiliation: c Nutrition Science, Beneo GmbH Obrigheim , Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Theis
authors.affiliation: b Paediatrics Research Unit , Universitat Rovira i Virgili, IISPV , Reus , Spain.|c Nutrition Science, Beneo GmbH Obrigheim , Germany.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Escribano
mesh_terms: D002675:Child, Preschool; D003248:Constipation / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry; D005260:Female; D005630:Fructans / Q000737:chemistry / Q000494:pharmacology*; D006801:Humans; D008297:Male; D010865:Pilot Projects
chemical_list: D005630:Fructans
keywords: Constipation; children; inulin; non-pharmacological treatment; prebiotics; stool consistency