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 journalArticle

1 Citation (Scopus)

Abstract

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
Volume49
Issue number3
Early online date25 Dec 2018
DOIs
Publication statusPublished - 28 Feb 2019

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Probiotics
Constipation
Microbiology
Randomized Controlled Trials
Placebos
Bifidobacterium
Quality of Life
Feces
Publications
Polymerase Chain Reaction
Bifidobacterium animalis

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Randomised clinical trial : Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation. / Dimidi, Eirini; Zdanaviciene, Ausra; Christodoulides, Stephanos; Taheri, Shiva; Louis, Petra; Duncan, Peter I.; Emami, Nashmil; Crabbé, Rafael; De Castro, C. Antonio; McLean, Peter; Bergonzelli, Gabriela E.; Whelan, Kevin; Mark Scott, S. (Corresponding Author).

In: Alimentary Pharmacology & Therapeutics, Vol. 49, No. 3, 28.02.2019, p. 251-264.

Research output: Contribution to journalArticle

Dimidi, E, Zdanaviciene, A, Christodoulides, S, Taheri, S, Louis, P, Duncan, PI, Emami, N, Crabbé, R, De Castro, CA, McLean, P, Bergonzelli, GE, Whelan, K & Mark Scott, S 2019, 'Randomised clinical trial: Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation', Alimentary Pharmacology & Therapeutics, vol. 49, no. 3, pp. 251-264. https://doi.org/10.1111/apt.15073
Dimidi, Eirini ; Zdanaviciene, Ausra ; Christodoulides, Stephanos ; Taheri, Shiva ; Louis, Petra ; Duncan, Peter I. ; Emami, Nashmil ; Crabbé, Rafael ; De Castro, C. Antonio ; McLean, Peter ; Bergonzelli, Gabriela E. ; Whelan, Kevin ; Mark Scott, S. / Randomised clinical trial : Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation. In: Alimentary Pharmacology & Therapeutics. 2019 ; Vol. 49, No. 3. pp. 251-264.
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abstract = "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.",
author = "Eirini Dimidi and Ausra Zdanaviciene and Stephanos Christodoulides and Shiva Taheri and Petra Louis and Duncan, {Peter I.} and Nashmil Emami and Rafael Crabb{\'e} and {De Castro}, {C. Antonio} and Peter McLean and Bergonzelli, {Gabriela E.} and Kevin Whelan and {Mark Scott}, S.",
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. ACKNOWLEDGEMENTS 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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T1 - Randomised clinical trial

T2 - Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation

AU - Dimidi, Eirini

AU - Zdanaviciene, Ausra

AU - Christodoulides, Stephanos

AU - Taheri, Shiva

AU - Louis, Petra

AU - Duncan, Peter I.

AU - Emami, Nashmil

AU - Crabbé, Rafael

AU - De Castro, C. Antonio

AU - McLean, Peter

AU - Bergonzelli, Gabriela E.

AU - Whelan, Kevin

AU - Mark Scott, S.

N1 - 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. ACKNOWLEDGEMENTS 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.

PY - 2019/2/28

Y1 - 2019/2/28

N2 - 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.

AB - 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.

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U2 - 10.1111/apt.15073

DO - 10.1111/apt.15073

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VL - 49

SP - 251

EP - 264

JO - Alimentary Pharmacology & Therapeutics

JF - Alimentary Pharmacology & Therapeutics

SN - 0269-2813

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