title: Fermented milk containing Bifidobacterium lactis DN-173 010 in childhood constipation: a randomized, double-blind, controlled trial.
abstract: BACKGROUND
  Constipation is a frustrating symptom affecting 3% of children worldwide. A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women. Our aim was to assess the effects of this product in constipated children.
  
  
  METHODS
  In this prospective randomized, double-blind, controlled trial, 159 constipated children (defecation frequency < 3 times per week) were randomly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 (n = 79) or a control product (n = 80) twice a day for 3 weeks. The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption. Analyses were by intention to treat.
  
  
  RESULTS
  Eleven children did not return to any follow-up visit (5 in the probiotic group, 6 in the control group) and were therefore excluded from the final analysis. Thus, 74 children in each group were analyzed. The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups, but the difference was not statistically significant (2.9 ± 3.2 in probiotic group versus 2.6 ± 2.6 in control group, P = .35). There were no serious adverse events.
  
  
  CONCLUSIONS
  In constipated children, the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency, but this increase was comparable in the control group. There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation.
authors: Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital Academic Medical Centre, Amsterdam, The Netherlands. m.m.tabbers@amc.nl
authors: Merit M
authors: MM
authors: Tabbers
authors: Ania
authors: A
authors: Chmielewska
authors: Maaike G
authors: MG
authors: Roseboom
authors: Nolwenn
authors: N
authors: Crastes
authors: Catherine
authors: C
authors: Perrin
authors: Johannes B
authors: JB
authors: Reitsma
authors: Obbe
authors: O
authors: Norbruis
authors: Hania
authors: H
authors: Szajewska
authors: Marc A
authors: MA
authors: Benninga