Fermented Milk Containing Bifidobacterium lactis DN-173 010 in Childhood Constipation: A Randomized, Double-Blind, Controlled Trial

Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital Academic Medical Centre, Amsterdam, The Netherlands.
PEDIATRICS (Impact Factor: 5.47). 06/2011; 127(6):e1392-9. DOI: 10.1542/peds.2010-2590
Source: PubMed


Constipation is a frustrating symptom affecting 3% of children worldwide. A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women. Our aim was to assess the effects of this product in constipated children.
In this prospective randomized, double-blind, controlled trial, 159 constipated children (defecation frequency < 3 times per week) were randomly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 (n = 79) or a control product (n = 80) twice a day for 3 weeks. The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption. Analyses were by intention to treat.
Eleven children did not return to any follow-up visit (5 in the probiotic group, 6 in the control group) and were therefore excluded from the final analysis. Thus, 74 children in each group were analyzed. The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups, but the difference was not statistically significant (2.9 ± 3.2 in probiotic group versus 2.6 ± 2.6 in control group, P = .35). There were no serious adverse events.
In constipated children, the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency, but this increase was comparable in the control group. There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation.

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    • "Bu et al. [17], showed that the use of Lactobacillus rhamnosus Lce35 increased evacuation frequency, however, there was no difference when compared to children who took oral laxatives. Two other studies [18,19] showed no evidence of improvement with constipated children using probiotics. "
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    ABSTRACT: Background Constipation is a frequent complaint and the combination of a prebiotic and probiotics could have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation. Methods Patients with constipation were randomly divided into two groups, Control Group (CG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Results Favourable clinical response was assessed since Agachan score had a significant reduction at the end of the study in both groups and tended to be better in the TG. The subjects in the treatment group also had a shorter transit time at the end of the intervention compared to the control group (p = 0.01). Conclusion The product containing yogurt with polydextrose, B. lactis HN019 and L. acidophilus NCFM® significantly shortened colonic transit time after two weeks in the TG compared to CG and may be an option for treatment of constipation.
    Nutrition Journal 07/2014; 13(1):75. DOI:10.1186/1475-2891-13-75 · 2.60 Impact Factor
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    • "Lcr35 8 9 108 CFU/day (250 mg/two capsules/b.i.d./4 weeks) 0.25 (0.1–0.61) Significant improvement with probiotic over placebo Tabbers et al. 2011 17 B. lactis DN-173 010 "
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    ABSTRACT: The microbiome located in the human gastrointestinal tract (GIT) comprises the largest community (diverse and dense) of bacteria, and in conjunction with a conducive internal milieu, promotes the development of regulated pro- and anti-inflammatory signals within the GIT that promotes immunological and metabolic tolerance. In addition, host-microbial interactions govern GIT inflammation and provide cues for upholding metabolic regulation in both the host and microbes. Failure to regulate inflammatory responses can increase the risk of developing inflammatory conditions in the GIT. Here, we review clinical studies regarding the efficacy of probiotics/prebiotics and the role they may have in restoring host metabolic homeostasis by rescuing the inflammatory response. The clinical studies reviewed included functional constipation, antibiotic-associated diarrhoea, Clostridium difficile diarrhoea, infectious diarrhoea/gastroenteritis, irritable bowel syndrome, inflammatory bowel diseases and necrotizing enterocolitis. We have demonstrated that there was an overall reduction in risk when probiotics were administered over placebo in the majority of GIT inflammatory conditions. The effect size of a cumulative reduction in relative risk for the GIT conditions/diseases investigated was 0.65 (0.61-0.70) (z = 13.3); p < 0.0001 that is an average reduction in risk of 35 % in favour of probiotics. We also progress a hypothesis that the GIT comprises numerous micro-axes (e.g. mucus secretion, Th1/Th2 balance) that are in operational homeostasis; hence probiotics and prebiotics may have a significant pharmacobiotic regulatory role in maintaining host GIT homeostasis in disease states partially through reactive oxygen species signalling.
    Inflammopharmacology 03/2014; 22(3). DOI:10.1007/s10787-014-0201-4
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    • "This follow-up study of children previously enrolled in 2 independent, randomized controlled trials [8] [9] showed that a substantial portion of the children remained symptomatic after 2–3 years of follow-up. Approximately one quarter of the children fulfilled the strict Rome III criteria for functional constipation or needed laxatives. "
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    ABSTRACT: Background: The goal of treatment of functional constipation (FC) is to restore a regular defecation pattern and to prevent relapses. Aim: To assess long-term outcomes in children with FC. Methods: This was a follow-up study of children previously enrolled in 2 independent randomized controlled trials. In the first trial, children randomly received glucomannan (GNN) or placebo for 4 weeks. In the second study, children received a fermented dairy product with Bifidobacterium lactis I-2494 (B. lactis) or placebo for 3 weeks. Follow-up data were collected using a standardized questionnaire. The primary outcome measure was treatment success (≥3 spontaneous bowel movements with no episodes of soiling during the last week, abdominal pain, or need for laxatives). The secondary outcomes were FC according to the Rome III criteria and the need for laxative therapy. Results: In the GNN study, follow-up data at 24 months were obtained from 63 of 72 (87.5%) of children. Treatment success was reported in 36/63 (57%), FC in 17/63 (27%), and the need for laxatives in 13/63 (21%). There were no differences in outcomes between groups. In the B. lactis study, follow-up data at 36 months were obtained from 57 of 82 (70%) of children. Treatment success was reported in 26/57 (46%), FC in 21/57 (37%), and the need for laxatives in 15/57 (26%). There were no differences in outcomes between groups. Conclusion: A substantial portion of children remained symptomatic after 2-3 years of follow-up indicating a need for regular evaluation of children with FC. © 2013 Polish Pediatric Society. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
    Pediatria polska 05/2013; 88(3):219-223. DOI:10.1016/j.pepo.2013.02.005
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