Clinical Trial: Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial

Brief Summary:

AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.

TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).


Detailed Summary: Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.
Sponsor: Medical University of Warsaw

Current Primary Outcome: Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission) [ Time Frame: Any time starting 72 h after admission ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period [ Time Frame: from the time of admission to the time of discharge of the hospital-expected average 3-5 days ]
  • Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea) [ Time Frame: during hospitalisation (expected average 3-5 days) and 72 h after discharge ]
  • Need and the length of intravenous rehydration due to diarrhea [ Time Frame: During the hospitalization-expected average 3-5 days ]
  • Prolongation of the hospitalization due to nosocomial diarrhea [ Time Frame: during the hospitalization-expected average 3-5 days ]
  • Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) [ Time Frame: 72 hours after admission to the hospital to 72 hours after discharge ]
    Positive test for rotavirus or antigen in the stool sample
  • Incidence of chronic diarrhea- lasting more than 14 days [ Time Frame: untill 14 days after onset of diarrhea ]
  • Length of hospital stay [ Time Frame: During hospitalisation-expected average 3-5 days ]
  • Adverse effects [ Time Frame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge ]


Original Secondary Outcome: Same as current

Information By: Medical University of Warsaw

Dates:
Date Received: September 3, 2012
Date Started: September 2012
Date Completion:
Last Updated: June 17, 2015
Last Verified: June 2015