Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial

Abstract

Bifidobacterium animalis subsp. lactis HN019 (HN019) ameliorates chronic idiopathic constipation. Our aim was to determine the efficacy and safety of 28-day supplementation with 1 × 109 or 1 × 1010 CFU of HN019/day for constipation. A total of 228 adults who were diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind and placebo-controlled trial. Colonic transit time (CTT), the primary outcome, and secondary outcomes that were measured using inventories—patient assessment of constipation symptoms (PAC-SYM) and quality of life (PAC-QoL), bowel function index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity—were assessed. Ancillary parameters and harms were also evaluated.There were no statistically significant differences in the primary or secondary outcomes between interventions. A post hoc analysis of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week) showed a physiologically relevant increase in weekly BMF in the high- (+2.0) and low-dose (+1.7) HN019 groups—by RMANOVA, the HN019 groups with BMF ≤ 3/week, pooled together, had a higher BMF versus placebo (P value = 0.01). Thus, improving low stool frequency could be a target of future interventions with HN019. High-dose HN019 also decreased the degree of straining at Day 28 versus placebo in those with BMF ≤ 3/week (P value = 0.02). Three unlikely related AEs—2 with low-dose HN019 and 1 with placebo—were followed until full recovery. In conclusion, although there were no differences in the primary analysis, HN019 is well tolerated and improves BMF in adults with low stool frequency.

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.…”

In vivo safety assessment of Lactobacillus fermentum strains, evaluation of their cholesterol‐lowering ability and intestinal microbial modulation

“…The human gut microbiota is a complex community and is important for the health status of the host . Alterations in the gut microbiota and diet have been found to be associated with the pathogenesis of several human diseases . Probiotic supplementation has been found to be associated with improvements in health and the intestinal microbial composition, and the supplementation of L. fermentum has been shown to modulate the intestinal microbiota in piglets .…”

“…[33][34][35] Alterations in the gut microbiota and diet have been found to be associated with the pathogenesis of several human diseases. [36][37][38][39][40] Probiotic supplementation has been found to be associated with improvements in health and the intestinal microbial composition, 24,41 and the supplementation of L. fermentum has been shown to modulate the intestinal microbiota in piglets. 42 As the global composition and the presence of pathogens or beneficial bacteria are relevant to the host's health, we analyzed the composition of the test animals over 13 weeks of feeding of bacterial strains.…”

Clostridium species as probiotics: potentials and challenges

“…and dietary fiber (the preferred nutrients for Clostridium spp.) [81,82]. This strategy tallys with the idea of microbial ecosystems therapeutics, which utilizes a mixture of defined bacteria or core microbiome to treat diseases [83].…”