Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial

Br J Nutr. 2015 Nov 28;114(10):1638-46. doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.


The aim of the present study was to investigate the effect of Bifidobacterium animalis subsp. lactis, BB-12®, on two primary end points - defecation frequency and gastrointestinal (GI) well-being - in healthy adults with low defecation frequency and abdominal discomfort. A total of 1248 subjects were included in a randomised, double-blind, placebo-controlled trial. After a 2-week run-in period, subjects were randomised to 1 or 10 billion colony-forming units/d of the probiotic strain BB-12® or a matching placebo capsule once daily for 4 weeks. Subjects completed a diary on bowel habits, relief of abdominal discomfort and symptoms. GI well-being, defined as global relief of abdominal discomfort, did not show significant differences. The OR for having a defecation frequency above baseline for ≥50% of the time was 1·31 (95% CI 0·98, 1·75), P=0·071, for probiotic treatment overall. Tightening the criteria for being a responder to an increase of ≥1 d/week for ≥50 % of the time resulted in an OR of 1·55 (95% CI 1·22, 1·96), P=0·0003, for treatment overall. A treatment effect on average defecation frequency was found (P=0·0065), with the frequency being significantly higher compared with placebo at all weeks for probiotic treatment overall (all P<0·05). Effects on defecation frequency were similar for the two doses tested, suggesting that a ceiling effect was reached with the one billion dose. Overall, 4 weeks' supplementation with the probiotic strain BB-12® resulted in a clinically relevant benefit on defecation frequency. The results suggest that consumption of BB-12® improves the GI health of individuals whose symptoms are not sufficiently severe to consult a doctor (ISRCTN18128385).

Keywords: AE adverse events; Bifidobacterium animalis subsp. lactis; Bowel habits; Defecation frequency; GI gastrointestinal; Gastrointestinal well-being; IBS irritable bowel syndrome; ITT intention-to-treat; PP per-protocol; Probiotics.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Abdominal Pain / therapy*
  • Adult
  • Bifidobacterium*
  • Defecation*
  • Double-Blind Method
  • Female
  • France
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Odds Ratio
  • Patient Compliance
  • Placebos
  • Probiotics / administration & dosage*
  • Probiotics / adverse effects
  • Surveys and Questionnaires
  • Time Factors
  • United Kingdom


  • Placebos

Associated data

  • ISRCTN/ISRCTN18128385