Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diarrhea

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM 17938
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L. reuteri DSM 17938<br>Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* 10(9) CFU/daily<br>|
| Placebo Comparator: Placebo<br>Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) | Positive test for rotavirus or antigen in the stool sample | 72 hours after admission to the hospital to 72 hours after discharge | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics