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PL02: Probiotic regimen for outpatient gastroenteritis utility of treatment (PROGUT) study: a multicenter randomized controlled trial

Published online by Cambridge University Press:  11 May 2018

S. Freedman
Affiliation:
University of Calgary, Calgary, AB
S. Williamson-Urquhart
Affiliation:
University of Calgary, Calgary, AB
K. Farion
Affiliation:
University of Calgary, Calgary, AB
S. Gouin
Affiliation:
University of Calgary, Calgary, AB
A. Willan
Affiliation:
University of Calgary, Calgary, AB
N. Poonai
Affiliation:
University of Calgary, Calgary, AB
K. Hurley
Affiliation:
University of Calgary, Calgary, AB
P. Sherman
Affiliation:
University of Calgary, Calgary, AB
Y. Finkelstein
Affiliation:
University of Calgary, Calgary, AB
B. Lee
Affiliation:
University of Calgary, Calgary, AB
X. Pang
Affiliation:
University of Calgary, Calgary, AB
L. Chui
Affiliation:
University of Calgary, Calgary, AB
D. Schnadower
Affiliation:
University of Calgary, Calgary, AB
J. Xie
Affiliation:
University of Calgary, Calgary, AB
M. Gorelick
Affiliation:
University of Calgary, Calgary, AB
S. Schuh
Affiliation:
University of Calgary, Calgary, AB

Abstract

Introduction: Gastroenteritis accounts for 1.7 million emergency department visits by children annually in the United States. We conducted a double-blind trial to determine whether twice daily probiotic administration for 5 days, improves outcomes. Methods: 886 children aged 348 months with gastroenteritis were enrolled in six Canadian pediatric emergency departments. Participants were randomly assigned to twice daily Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052, 4.0 x 109 CFU, in a 95:5 ratio or placebo. Primary outcome was development of moderate-severe disease within 14 days of randomization defined by a Modified Vesikari Scale score 9. Secondary outcomes included duration of diarrhea and vomiting, subsequent physician visits and adverse events. Results: Moderate-severe disease occurred in 108 (26.1%) participants administered probiotics and 102 (24.7%) participants allocated to placebo (OR 1.06; 95%CI: 0.77, 1.46; P=0.72). After adjustment for site, age, and frequency of vomiting and diarrhea, treatment assignment did not predict moderate-severe disease (OR, 1.11, 95%CI, 0.80 to 1.56; P=0.53). In the probiotic versus placebo groups, there were no differences in the median duration of diarrhea [52.5 (18.3, 95.8) vs. 55.5 (20.2, 102.3) hours; P=0.31], vomiting [17.7 (0, 58.6) vs. 18.7 (0, 51.6) hours; P=0.18], physician visits (30.2% vs. 26.6%; OR 1.19; 95% CI0.87. 1.62; P=0.27), or adverse events (32.9% vs. 36.8%; OR 0.83; 95%CI 0.62. 1.11; P=0.21). Conclusion: In children presenting to an emergency department with gastroenteritis, twice daily administration of 4.0 x 109 CFU of a Lactobacillus rhamnosus/helveticus probiotic does not prevent development of moderate-severe disease or improvements in other outcomes measured.

Type
Plenary Oral Presentations
Copyright
Copyright © Canadian Association of Emergency Physicians 2018 
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PL02: Probiotic regimen for outpatient gastroenteritis utility of treatment (PROGUT) study: a multicenter randomized controlled trial
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