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

摘要

The aim of the present study was to investigate the effect of Bifidobacterium animalis subsp. lactis, BB-12 (R), 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 (R) 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 1.5 (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 P0.05). 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 (R) resulted in a clinically relevant benefit on defecation frequency. The results suggest that consumption of BB-12 (R) improves the GI health of individuals whose symptoms are not sufficiently severe to consult a doctor (ISRCTN18128385).