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

Abstract

Summary 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.

Metabologenomics identified fecal biomarkers for bowel movement regulation byBifidobacterium longumcapsules: an RCT

“…We established an accurate Bayesian statistical model to estimate the bowel movement frequency-increasing effect due to B. longum BB536 intake, and this model revealed which subjects were responders or NRs in this study. This model enabled us to detect shortening of the bowel movement interval due to the intake of B. longum BB536, which is consistent with previous research [15,16]. In addition, because Bayesian estimation of the parameters enabled us to calculate a correct interval, this model achieved accurate quantitative evaluation of the effect of B. longum BB536 intake on bowel movement frequency, which has been difficult to achieve by threshold-based responder estimation [21].…”

“…Bifidobacterium is a representative microbial genus of probiotics that is frequently used to regulate bowel movements [10]. Multiple randomized controlled trials have shown that bifidobacteria intake increases bowel movement frequency [11][12][13][14] or shortens gut transit time [15,16]. However, the response to bifidobacteria supplementation varies from subject to subject.…”

Probiotics and constipation: mechanisms of action, evidence for effectiveness and utilisation by patients and healthcare professionals

“…Although the impact of probiotics on the microbiota in constipation is not well understood, a small number of trials have demonstrated significant changes in gut microbiota composition following probiotic supplementation (16) . For example, supplementation of Bifidobacterium lactis GCL2505 or Lactobacillus casei Shirota increased concentration of bifidobacteria, however B. lactis NCC2818 and VSL#3, a multi-strain probiotic, had no impact on gut microbiota composition (19)(20)(21)(22) . These results suggest that administration of probiotics may impact on certain microbiota components, but it is yet to be determined what impact this change has on constipation, and whether effects are mediated through microbiota modification or other mechanisms.…”

Prebióticos e probióticos na saúde e no tratamento de doenças intestinais: uma revisão integrativa

“…Estudos com probióticos e prebióticos na constipação idiopática crônica. Research, Society and Development, v. 9, n. 10, e6459109071, 2020 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i10.9071 referidos como validados, em combinação com a escala de Bristol ou com outros questionários ou, ainda, de forma isolada (Yoon et al, 2018;Ibarra et al, 2018;Dimidi et al, 2019). Três ensaios analisaram o tempo de trânsito colônico com marcador radiopaco (Magro et al, 2014;Ibarra et al, 2018;Dimidi et al, 2019) e dois empregaram a metodologia da autopercepção/autoavaliação dos sintomas pelos pacientes, por meio do uso de um diário de relato (Jayasimhan et al, 2013;Glibowski et al, 2020).…”