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

• Published in: British journal of nutrition Vol. 114; no. 10; pp. 1638 - 1646
• Main Authors: Eskesen, Dorte, Jespersen, Lillian, Michelsen, Birgit, Whorwell, Peter J., Müller-Lissner, Stefan, Morberg, Cathrine M.
• Format: Journal Article
• Language: English
• Published: Cambridge, UK Cambridge University Press 28.11.2015
• Subjects: Abdominal Pain - therapy; Adult; adults; Bifidobacterium; Bifidobacterium animalis subsp. lactis; Defecation; Diet; Double-Blind Method; Excretory system; Female; France; gastrointestinal system; Germany; Human and Clinical Nutrition; Humans; Male; Middle Aged; Nutrition; Odds Ratio; Patient Compliance; Placebos; Probiotics; Probiotics - administration & dosage; Probiotics - adverse effects; Surveys and Questionnaires; Time Factors; United Kingdom; Probiotics; Gastrointestinal well-being; Bowel habits; Bifidobacterium animalis subsp. lactis; Defecation frequency; IBS irritable bowel syndrome; PP per-protocol; GI gastrointestinal; ITT intention-to-treat; AE adverse events
• DOI: 10.1017/S0007114515003347
• ISSN: 0007-1145; 1475-2662

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).