Clinical trial NCT01968408: Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
Official title: Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: nosocomial diarrhea
Lactobacillus reuteri DSM 17938
rotavirus diarrhea
probiotics
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 184
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
* Signed informed consent.

Exclusion Criteria:

* Acute gastroenteritis within 3 days before admission
* Symptoms other than diarrhea suggesting gastroenteritis
* Use of probiotics within 7 days before admission
* Immunodeficiency disorders
* Breastfeeding \>50%
* Underlying gastrointestinal tract disorder
* Malnutrition (weight/high \<3pc)

Primary outcomes:
measure: 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)
timeFrame: Any time starting 72 h after admission
Secondary outcomes:
measure: Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period
timeFrame: from the time of admission to the time of discharge of the hospital-expected average 3-5 days
measure: Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)
timeFrame: during hospitalisation (expected average 3-5 days) and 72 h after discharge
measure: Need and the length of intravenous rehydration due to diarrhea
timeFrame: During the hospitalization-expected average 3-5 days
measure: Prolongation of the hospitalization due to nosocomial diarrhea
timeFrame: during the hospitalization-expected average 3-5 days
measure: Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
timeFrame: 72 hours after admission to the hospital to 72 hours after discharge
measure: Incidence of chronic diarrhea- lasting more than 14 days
timeFrame: untill 14 days after onset of diarrhea
measure: Length of hospital stay
timeFrame: During hospitalisation-expected average 3-5 days
measure: Adverse effects
timeFrame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatrics, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Hanna Szajewska, MD, Profesor
role: PRINCIPAL_INVESTIGATOR
References: