Randomised clinical trial: Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation

Eirini Dimidi, Ausra Zdanaviciene, Stephanos Christodoulides, Shiva Taheri, Petra Louis, Peter I. Duncan, Nashmil Emami, Rafael Crabbé, C. Antonio De Castro, Peter McLean, Gabriela E. Bergonzelli, Kevin Whelan, S. Mark Scott (Corresponding Author)

Research output: Contribution to journalArticlepeer-review

47 Citations (Scopus)


Background Constipation is a prevalent gastrointestinal disorder. Patient dissatisfaction with prescribed medications is common, and there is need for alternative management strategies. Evidence shows that Bifidobacterium species may be beneficial in constipation. Aim To investigate changes in physiological and clinical measures of gut function in patients with chronic constipation following the consumption of Bifidobacterium lactis NCC2818, compared to placebo. Methods Participants were randomised to a 4-week supplementation with B. lactis NCC2818 (1.5 x 1010 CFU/d) or placebo. Gut transit time was measured using a radio-opaque marker, while symptoms and quality of life were assessed using validated questionnaires. Gut microbiota composition was assessed using quantitative polymerase chain reaction. Analysis of covariance was used for normally distributed variables, and Mann-Whitney test for non-normally distributed variables. Results Seventy-five participants were randomised. There was no significant difference between the probiotic and placebo groups in gut transit time change from baseline to week 2 (?11.7 hours, SD 33.0 hours vs ?12.9 hours, SD 33.6 hours; P = 0.863) or to week 4 (?20.4 hours, SD 32.5 h vs ?8.7 hours, SD 33.8 hours; P = 0.103). There were also no improvements in stool output, symptoms, or quality of life. No differences were found in Bifidobacterium concentrations between the probiotic and placebo groups at week 4 (9.5 log10/g dry faeces, SD 0.3 vs 9.4 log10/g, SD 1.0; P = 0.509). Conclusions Bifidobacterium lactis NCC2818 was not effective in the management of mild chronic constipation. This study highlights the importance of further studies and their publication to better understand the strain-specific effects of probiotics.
Original languageEnglish
Pages (from-to)251-264
Number of pages14
JournalAlimentary Pharmacology & Therapeutics
Issue number3
Early online date25 Dec 2018
Publication statusPublished - 28 Feb 2019

Bibliographical note

Funding information: This study was funded in full by Nestec SA. The funder was involved in the planning of the study, as well as the statistical analysis and interpretation of the data.

Freda Farquharson provided the standard solutions necessary for the microbiology analysis. Maurice Beaumont and Tiago Nunes (Nestec SA) contributed in the preparation of the study design. PL received support from the Scottish Government Rural and Environment Science and Analytical Services Division.


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