title: A randomized, double-blind, controlled study and pooled analysis of two identical trials of fermented milk containing probiotic Bifidobacterium lactis CNCM I-2494 in healthy women reporting minor digestive symptoms.
abstract: BACKGROUND
  The probiotic fermented milk (PFM) containing Bifidobacterium lactis CNCM I-2494 improved gastrointestinal (GI) well-being and digestive symptoms in a previous trial involving women reporting minor digestive symptoms. Our objective is to confirm these findings in a second study and in a pooled analysis of both studies.
  
  
  METHODS
  In this double-blind, controlled, parallel design study, subjects without diagnosed GI disorders consumed PFM or control dairy product daily for 4 weeks. Endpoints comprised weekly assessment of GI well-being (primary endpoint), rate of responders and digestive symptoms. Data were analyzed on full analysis set population (n = 324) and on the pooled data of randomized subjects of this study with those of the first study (n = 538).
  
  
  RESULTS
  In this second study, no significant difference was observed in the percentage of women reporting an improvement in GI well-being [OR = 1.20 (95% CI 0.87, 1.66)] and rate of responders [OR = 1.38 (95% CI 0.89, 2.14)]. Composite score of digestive symptoms was significantly (P < 0.05) reduced in PFM when compared to the control group [LSmean = -0.42 (95% CI -0.81, -0.03)]. In the pooled analysis, significant differences were observed in favor of PFM group for all endpoints: percentage of women with improved GI well-being [OR = 1.36 (95% CI 1.07, 1.73)], rate of responders [OR = 1.53 (95% CI 1.09, 2.16)] and composite score of digestive symptoms [LSmean = -0.48 (95% CI -0.80, -0.16)].
  
  
  CONCLUSIONS
  This second study did not confirm improvement on the primary endpoint. However, a pooled analysis of the two trials showed improvement in GI well-being and digestive symptoms in women reporting minor digestive symptoms.
authors.affiliation: Department of digestive diseases, AP-HP, Lariboisière Hospital, University Denis Diderot, Paris, France. philippe.marteau@lrb.aphp.fr
authors.forename: P
authors.initials: P
authors.lastname: Marteau
authors.forename: D
authors.initials: D
authors.lastname: Guyonnet
authors.forename: P
authors.initials: P
authors.lastname: Lafaye de Micheaux
authors.forename: S
authors.initials: S
authors.lastname: Gelu
mesh_terms: D000293:Adolescent; D000328:Adult; D001644:Bifidobacterium; D043302:Cultured Milk Products; D004063:Digestion / Q000502:physiology; D004066:Digestive System Diseases / Q000175:diagnosis* / Q000178:diet therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*; D055815:Young Adult