title: 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.
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).
authors.affiliation: 1Chr. Hansen A/S,2970 Hørsholm,Denmark.
authors.forename: Dorte
authors.initials: D
authors.lastname: Eskesen
authors.affiliation: 1Chr. Hansen A/S,2970 Hørsholm,Denmark.
authors.forename: Lillian
authors.initials: L
authors.lastname: Jespersen
authors.affiliation: 1Chr. Hansen A/S,2970 Hørsholm,Denmark.
authors.forename: Birgit
authors.initials: B
authors.lastname: Michelsen
authors.affiliation: 2Centre for Gastrointestinal Sciences,University Hospital of South Manchester,Manchester M23 9LT,UK.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Whorwell
authors.affiliation: 3Park-Klinik Weissensee,13086 Berlin,Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Lissner
authors.affiliation: 1Chr. Hansen A/S,2970 Hørsholm,Denmark.
authors.forename: Cathrine M
authors.initials: CM
authors.lastname: Morberg
mesh_terms: D015746:Abdominal Pain / Q000628:therapy*; D000328:Adult; D001644:Bifidobacterium; D003672:Defecation; D004311:Double-Blind Method; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010349:Patient Compliance; D010919:Placebos; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D006113:United Kingdom
chemical_list: D010919:Placebos
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