Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial

Phase 4CompletedNCT02871908

Medical University of Warsaw250 enrolled

Overview

The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.

Introduction: Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children. Methods and analysis: A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10\^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

250

Conditions

Diarrhea Antibiotic Associated Diarrhea

Interventions

Lactobacillus reuteri DSM 17938DRUG

Lactobacillus reuteri DSM 17938 twice daily 2 x 10\^8

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age younger than 18 years; * oral or intravenous antibiotic therapy which started within 24 hours of enrollment; * signed informed consent. Exclusion Criteria: * pre-existing acute or chronic diarrhea, * history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency, * use of probiotics within 2 weeks prior to enrollment, * use of antibiotics within 4 weeks prior to enrollment, * prematurity, and exclusive breastfeeding.

Locations (1)

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, Poland

Outcomes

Primary Outcomes

frequencies of diarrhea and antibiotic associated diarrhea

Three different definitions of diarrhea will be used, as the definitions of diarrhea/AAD in published studies vary. These will include diarrhea defined as: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment, and (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e., negative laboratory stool tests for infectious agents). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS.