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
- 2015-09-18
- British Journal of Nutrition 114(10)
- D. Eskesen
- L. Jespersen
- B. Michelsen
- P. Whorwell
- S. Müller-lissner
- Cathrine M Morberg
- PubMed: 26382580
- DOI: 10.1017/S0007114515003347
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).
Keywords: AE adverse events; Bifidobacterium animalis subsp. lactis; Bowel habits; Defecation frequency; GI gastrointestinal; Gastrointestinal well-being; IBS irritable bowel syndrome; ITT intention-to-treat; PP per-protocol; Probiotics.
Research Insights
Supplement | Health Outcome | Effect Type | Effect Size |
---|---|---|---|
Bifidobacterium animalis | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium animalis subsp. lactis | Reduced Abdominal Discomfort | Neutral | Small |
Bifidobacterium animalis subsp. lactis B420 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis B420 | Improved Intestinal Function | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis BB-12 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis BB-12 | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium animalis subsp. lactis BLC1 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis BS-01 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis BS-01 | Improved Intestinal Function | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis CECT 8145 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis CECT 8145 | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium animalis subsp. lactis LAFTI B94 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis LAFTI B94 | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium animalis subsp. lactis VK2 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium animalis subsp. lactis VK2 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium animalis subsp. lactis VK2 | Improved Stool Frequency | Beneficial | Moderate |
Bifidobacterium bifidum BB01 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium bifidum BB01 | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium bifidum/lactis Bb-02 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium bifidum/lactis Bb-02 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis B420 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis B420 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis Bb-02 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis Bb-02 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium lactis BB-12 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis BB-12 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis BB-12 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium lactis BI-04 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis BI-04 | Reduced Abdominal Discomfort | Neutral | Small |
Bifidobacterium lactis Bi-07 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis Bi-07 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis Bi-07 | Increased Stool Frequency | Beneficial | Moderate |
Bifidobacterium lactis Bl-04 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis Bl-04 | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium lactis BL818 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis BL818 | Increased Defecation Frequency | Beneficial | Moderate |
Bifidobacterium lactis BLA80 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis BLA80 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium lactis BLA80 | Increased Defecation Frequency | Beneficial | Moderate |
Bifidobacterium lactis BLC-1 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis BLC-1 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium lactis HA-194 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis HA-194 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis HDS Bb-02 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis HDS Bb-02 | Improved Gastrointestinal Well-Being | Neutral | Small |
Bifidobacterium lactis HDS Bb-02 | Increased Defecation Frequency | Beneficial | Moderate |
Bifidobacterium lactis ISS Bif | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis MAK16B42L | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis MAK16B42L | Improved Intestinal Function | Beneficial | Moderate |
Bifidobacterium lactis MAK16B42L | Reduced Abdominal Pain | Neutral | Small |
Bifidobacterium lactis SD-5219 | Improved Bowel Movement Frequency | Beneficial | Moderate |
Bifidobacterium lactis SD-5219 | Improved Gastrointestinal Health | Beneficial | Moderate |
Bifidobacterium lactis UABla-12 | Improved Bowel Movement Frequency | Beneficial | Moderate |
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