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      Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial

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          Abstract

          Background:

          To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases (CIDs) and the change of behavior because of illness in children.

          Subjects/Methods:

          We conducted a double-blinded, randomized, placebo-controlled allocation concealment clinical trial in the Washington, DC metropolitan area. Participants were 638 children 3–6 years old in daycare/schools. The intervention was a fermented dairy drink containing a specific probiotic strain or matching placebo with no live cultures for 90 consecutive days. Two primary outcomes were assessed: incidence of CIDs and change of behavior because of illness (both assessed by parental report).

          Results:

          The rate of change of behavior because of illness was similar among active and control groups. However, the incidence rate for CIDs in the active group (0.0782) is 19% lower than that of the control group (0.0986) (incidence rate ratio=0.81, 95% CI: 0.65, 099) P=0.046.

          Conclusions:

          Daily intake of a fermented dairy drink containing the probiotic strain L. casei DN-114 001 showed some promise in reducing overall incidence of illness, but was primarily driven by gastrointestinal infections and there were no differences in change of behavior.

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          Most cited references 30

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          Surrogate end points in clinical trials: are we being misled?

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            Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children.

            The objective of this study was to determine the efficacy of Lactobacillus casei sps. rhamnosus (Lactobacillus GG) (LGG) in reducing the incidence of antibiotic-associated diarrhea when coadministered with an oral antibiotic in children with acute infectious disorders. Two hundred two children between 6 months and 10 years of age were enrolled; 188 completed all phases of the protocol. LGG, 1 x 10(10) - 2 x 10(10) colony forming units per day, or comparable placebo was administered in a double-blind randomized trial to children receiving oral antibiotic therapy in an outpatient setting. The primary caregiver was questioned every 3 days regarding the incidence of gastrointestinal symptoms, predominantly stool frequency and consistency, through telephone contact by blinded investigators. Twenty-five placebo-treated but only 7 LGG-treated patients had diarrhea as defined by liquid stools numbering 2 or greater per day. Lactobacillus GG overall significantly reduced stool frequency and increased stool consistency during antibiotic therapy by the tenth day compared with the placebo group. Lactobacillus GG reduces the incidence of antibiotic-associated diarrhea in children treated with oral antibiotics for common childhood infections.
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              Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

              We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants. A prospective, masked, randomized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW ( or= stage 2). Three hundred sixty-seven infants were enrolled: 180 in the study group and 187 in the control group. The demographic and clinical variables were similar in both groups. The incidence of death or NEC (>or= stage 2) was significantly lower in the study group (9 of 180 vs 24 of 187). The incidence of NEC (>or= stage 2) was also significantly lower in the study when compared with the control group (2 of 180 vs 10 of 187). There were 6 cases of severe NEC (Bell stage 3) in the control group and none in the study group. None of the positive blood culture grew Lactobacillus or Bifidobacterium species. Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants.
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                Author and article information

                Journal
                Eur J Clin Nutr
                European Journal of Clinical Nutrition
                Nature Publishing Group
                0954-3007
                1476-5640
                July 2010
                19 May 2010
                : 64
                : 7
                : 669-677
                Affiliations
                [1 ]Department of Family Medicine, Georgetown University Medical Center , Washington, DC, USA
                [2 ]Medstar Research Institute , Hyattsville, MD, USA
                [3 ]Dairy & Food Culture Technologies , Centennial, CO, USA
                [4 ]The Dannon Company, Inc. , White Plains, NY, USA
                [5 ]Danone Research , Palaiseau, France
                [6 ]Department of Medicine, Georgetown University Medical Center , Washington, DC, USA
                Author notes
                [* ]Department of Family Medicine, Georgetown University Medical Center , 3800 Reservoir Road, NW, 417 Kober Cogan Hall, Washington, DC 20007, USA. E-mail: djm23@ 123456georgetown.edu
                Article
                ejcn201065
                10.1038/ejcn.2010.65
                2906750
                20485304
                Copyright © 2010 Macmillan Publishers Limited

                This work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/

                Categories
                Original Article

                Nutrition & Dietetics

                functional foods, infections, clinical trial, probiotics

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