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
The British journal of nutrition 114(10)

PubMed: 26382580
DOI: 10.1017/s0007114515003347

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 1,248
Population: 1248 subjects in healthy adults with low defecation frequency and abdominal discomfort
Methods: 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 Bifidobacterium animalis subsp. lactis, BB-12® or a matching placebo capsule once daily for 4 weeks

Large Human Trial

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).

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Bifidobacterium animalis subsp. lactis BB-12	—	Improved Bowel Movement Frequency	Beneficial	Moderate	View source Overall, 4 weeks' supplementation with the probiotic strain BB-12® resulted in a clinically relevant benefit on defecation frequency.
Bifidobacterium animalis subsp. lactis BB-12	—	Improved Defecation Condition	Beneficial	Moderate	View source 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)... Overall, 4 weeks' supplementation with the probiotic strain BB-12® resulted in a clinically relevant benefit on defecation frequency.
Bifidobacterium animalis subsp. lactis BB-12	—	Improved Gastrointestinal Well-Being	Neutral	Small	View source GI well-being, defined as global relief of abdominal discomfort, did not show significant differences.
Bifidobacterium animalis subsp. lactis BB-12	—	Increased Defecation Frequency	Beneficial	Moderate	View source 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).
Bifidobacterium animalis subsp. lactis BB-12	—	No Significant Improvement in Global Gastrointestinal Well-being	Neutral	Small	View source GI well-being, defined as global relief of abdominal discomfort, did not show significant differences.