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

The British Journal of Nutrition
Q1
Sep 2015
Citations:67
Influential Citations:4
Interventional (Human) Studies
81
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Methods
Randomized, double-blind, placebo-controlled, parallel-group trial at eight centers in France, Germany and the UK; 2-week run-in; 4-week intervention; healthy men and women aged 18–70 years with low defecation frequency (2–4 d/week) and abdominal discomfort; total randomized: 1248.
Intervention
BB-12 capsules containing 1 billion CFU or 10 billion CFU per capsule; one capsule daily with breakfast; duration 4 weeks.
Results
BB-12 daily for 4 weeks increased defecation frequency in healthy adults with low baseline frequency and mild abdominal discomfort. In ITT, responder rate for ≥50% of weeks above baseline did not reach significance (OR 1.31; 95% CI 0.98–1.75; P=0.071). A stricter post hoc responder criterion showed a significant effect (OR 1.55–1.96; P=0.0003). Average weekly defecation frequency rose over 4 weeks, significantly higher than placebo at all weeks (P<0.05). Doses had similar effects, indicating a ceiling effect at 1 billion CFU. GI well-being did not differ; abdominal pain and bloating decreased similarly across groups; stool consistency slightly softened in all groups. Adverse events were similar across groups; few were related to treatment. Conclusion: 4 weeks of BB-12 daily improves defecation frequency in this population, with similar efficacy at both doses and no observed benefit for GI well-being. BB-12 appears safe; further research is needed to understand mechanisms and GI well-being assessment.
Limitations
High placebo response; reliance on self-reported outcomes; use of post hoc responder criteria; results may not generalize to IBS or more severe GI symptoms; GI well-being endpoint may be suboptimal; short duration and run-in period.

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 ...