Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Medical University of Warsaw

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus reuteri DSM 17938

Study type: Interventional

Funder types: Other

Identifiers

NCT01968408

KB/125/2012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 1 to 48 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups, including a placebo group

L. reuteri DSM 17938

Active Comparator group

Description:

Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo

Placebo Comparator group

Description:

Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization

Treatment:

Dietary Supplement: Placebo