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

Neurogastroenterol Motil. 2013 Apr;25(4):331-e252. doi: 10.1111/nmo.12078. Epub 2013 Mar 11.

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).

Key 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 & inferences: 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.

Publication types

  • Meta-Analysis
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Bifidobacterium*
  • Cultured Milk Products*
  • Digestion / physiology
  • Digestive System Diseases / diagnosis*
  • Digestive System Diseases / diet therapy*
  • Digestive System Diseases / physiopathology
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Probiotics / administration & dosage*
  • Young Adult