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.

Dorte Eskesen, Lillian Jespersen, Birgit Michelsen, Peter Whorwell, Stefan Müller-Lissner, Cathrine M Morberg

    Research output: Contribution to journalArticlepeer-review

    Abstract

    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
    Original languageEnglish
    Pages (from-to)1638-1646
    Number of pages9
    JournalThe British Journal of Nutrition
    Volume114
    Issue number10
    Early online date18 Sept 2015
    DOIs
    Publication statusPublished - Nov 2015

    Keywords

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

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