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Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.
Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.
Patients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Lactobacillus reuteri (DSM 17938)
The Medical University of Warsaw, Department of Paediatrics
Warsaw Medical University
Published on BioPortfolio: 2014-08-27T03:16:46-0400
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A species of gram-positive, rod-shaped LACTIC ACID bacteria found naturally in the human intestinal flora and BREAST MILK.
A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and ORAL MUCOSA. It produces BACTERIOCINS and is used as a PROBIOTIC.
A species of Lactobacillus that occurs in fermented meat and fish. It produces the BACTERIOCIN Sakacin P and is used for FOOD PRESERVATION and as a PROBIOTIC.
A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and VAGINA. It produces BACTERIOCINS and HYDROGEN PEROXIDE and is used as a PROBIOTIC.
A species of Lactobacillus that occurs in the human ORAL MUCOSA; GASTROINTESTINAL TRACT; and VAGINA. It produces BACTERIOCINS, can modulate the immune response, and is used as a PROBIOTIC.
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