Diarrhea
Conditions
Keywords
nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri DSM 17938
10(9) CFU/daily
DIETARY_SUPPLEMENTPlacebo
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 48 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Any time starting 72 h after admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea) | during hospitalisation (expected average 3-5 days) and 72 h after discharge | — |
| Need and the length of intravenous rehydration due to diarrhea | During the hospitalization-expected average 3-5 days | — |
| Prolongation of the hospitalization due to nosocomial diarrhea | during the hospitalization-expected average 3-5 days | — |
| Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period | from the time of admission to the time of discharge of the hospital-expected average 3-5 days | — |
| Incidence of chronic diarrhea- lasting more than 14 days | untill 14 days after onset of diarrhea | — |
| Length of hospital stay | During hospitalisation-expected average 3-5 days | — |
| Adverse effects | During hospitalisation (expected average 3-5 days) plus 72 h after discharge | — |
| Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) | 72 hours after admission to the hospital to 72 hours after discharge | Positive test for rotavirus or antigen in the stool sample |
Countries
Poland
Outcome results
None listed