title: Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial.
abstract: BACKGROUND
  Health-related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS).
  
  
  OBJECTIVE
  To study the effects of fermented milk containing Bifidobacterium animalis DN-173 010 and yoghurt strains on the IBS in a multicentre, double-blind, controlled trial.
  
  
  METHODS
  A total of 274 primary care adults with constipation-predominant IBS (Rome II) were randomized to consume for 6 weeks either the test fermented milk or a heat-treated yoghurt (control). HRQoL and digestive symptoms were assessed after 3 and 6 weeks on an intention-to-treat population of 267 subjects.
  
  
  RESULTS
  The HRQoL discomfort score, the primary endpoint, improved (P < 0.001) in both groups at weeks 3 and 6. The responder rate for the HRQoL discomfort score was higher (65.2 vs. 47.7%, P < 0.005), as was the decrease in bloating score [0.56 +/- (s.d.)1.01 vs. 0.31 +/- 0.87, P = 0.03], at week 3 in the test vs. the control group. In those subjects with <3 stools/week, stool frequency increased (P < 0.001) over 6 weeks in the test vs. control group.
  
  
  CONCLUSIONS
  This study suggests a beneficial effect of a probiotic food on discomfort HRQoL score and bloating in constipation-predominant IBS, and on stool frequency in subjects with <3 stools/week.
authors.affiliation: Danone Research, Route Départementale 128, 91767 Palaiseau, France. denis.guyonnet@danone.com
authors.forename: D
authors.initials: D
authors.lastname: Guyonnet
authors.forename: O
authors.initials: O
authors.lastname: Chassany
authors.forename: P
authors.initials: P
authors.lastname: Ducrotte
authors.forename: C
authors.initials: C
authors.lastname: Picard
authors.forename: M
authors.initials: M
authors.lastname: Mouret
authors.forename: C-H
authors.initials: CH
authors.lastname: Mercier
authors.forename: C
authors.initials: C
authors.lastname: Matuchansky
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D039941:Bifidobacteriales Infections / Q000382:microbiology* / Q000628:therapy; D001644:Bifidobacterium; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000382:microbiology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D019936:Probiotics / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D015014:Yogurt / Q000382:microbiology*