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
What this study found
BB-12 improved defecation frequency versus placebo after 4 weeks, with similar benefit at both doses and no clear dose-response. Change from baseline in defecation frequency was 1.54 days/week in the 1 billion CFU group, 1.30 in the 10 billion CFU group, and 1.15 in the placebo group; the odds of having a defecation frequency above baseline for at least 2 of 4 weeks was 1.31 (95% CI 0.98, 1.75) for probiotic treatment overall. A stricter post hoc responder analysis gave odds ratios of 1.50 to 1.61 for each dose and overall treatment. Gastrointestinal well-being did not differ significantly…
- Study & population
- This was an eight-center, randomized, double-blind, placebo-controlled, parallel-group trial conducted in France, Germany, and the United Kingdom between September 2010 and December 2012.
- Intervention
- Participants received an oral BB-12 probiotic capsule containing Bifidobacterium animalis subsp.
- Key limitation
- The intervention lasted only 4 weeks, so durability of benefit is unknown.
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Open PDFOriginal 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<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).