title: Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial.
abstract: To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children.
  
  
  
  A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged <5 years with functional constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 108colony-forming units, n = 48) or placebo (n = 46), twice daily, for 4 weeks. The primary outcome measure was treatment success, defined as 3 or more spontaneous stools per week, without episodes of fecal soiling, in the last week of the intervention. Analyses were by intention to treat.
  
  
  
  Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P < .001) and in the Lcr35 group (2.0 [1.0, 2.0] to 4.0 [3.0, 5.0], P < .001), but the defecation frequency in the placebo group was significantly greater than that in the Lcr35 group at weeks 1, 2, 3, and 4.
  
  
  
  Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation in children <5 years. This study adds to current recommendations that do not support the use of probiotics in the treatment of childhood constipation.
  
  
  
  ClinicalTrials.gov: NCT01985867.
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Wojtyniak
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Horvath
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Dziechciarz
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
mesh_terms: D001691:Biological Therapy; D002675:Child, Preschool; D003248:Constipation / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007780:Lacticaseibacillus casei; D052201:Lacticaseibacillus rhamnosus; D008297:Male
keywords: gastrointestinal disorders; pediatrics; probiotics