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Open Access Study protocol

Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial

Stephen B Freedman1*, Sarah Williamson-Urquhart2, Suzanne Schuh3, Philip M Sherman4, Ken J Farion56, Serge Gouin7, Andrew R Willan8, Ron Goeree10, David W Johnson11, Karen Black12, David Schnadower9, Marc H Gorelick13 and on behalf of the Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group

Author Affiliations

1 Sections of Paediatric Emergency Medicine and Gastroenterology, Alberta Children’s Hospital, Alberta Children’s Hospital Research Institute, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB T3B 6A8, Canada

2 Paediatric Emergency Research Team, Alberta Children’s Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB T3B 6A8, Canada

3 Division of Paediatric Emergency Medicine, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, ON M5G 1X8, Canada

4 Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, ON M5G 1X8, Canada

5 Departments of Pediatrics and Emergency Medicine, University of Ottawa, 401 Smyth Road, Ottawa, ON K1H8L1, Canada

6 Emergency Department, Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON K1H8L1, Canada

7 Division of Paediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Ste-Justine, Université de Montréal, 3175 Côte-Sainte-Catherine, Montréal, Québec H3T1C5, Canada

8 Program in Child Health Evaluative Sciences, SickKids Research Institute, Dalla Lana School of Public Health, University of Toronto, 555 University Avenue, Toronto, ON M5G 1X8, Canada

9 Division of Pediatric Emergency Medicine, Washington University School of Medicine, 660 S. Euclid Avenue, Campus Box 8116, St. Louis 63110MO, USA

10 PATH Research Institute, St. Joseph's Healthcare Hamilton, Department of Clinical Epidemiology and Biostatistics, McMaster University, 25 Main Street West, Suite 2000, Hamilton, ON L8P1H1, Canada

11 Departments of Pediatrics and Physiology and Pharmacology, Faculty of Medicine, Alberta Children’s Hospital Research Institute, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB T3B 6A8, Canada

12 Division of Pediatric Emergency Medicine, University of British Columbia, BC Children’s Hospital, 4480 Oak St, Vancouver, BC V6H3N1, Canada

13 Department of Pediatrics, Medical College of Wisconsin, Children’s Hospital of Wisconsin, 8915 W. Connell Ave., P.O. Box 1997, Milwaukee, WI 53226, USA

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Trials 2014, 15:170  doi:10.1186/1745-6215-15-170

Published: 14 May 2014

Abstract

Background

The burden of acute gastroenteritis on children and their families continues to be enormous. Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although clinical trials in children with gastroenteritis have been performed, most have significant flaws, and guidelines do not consistently endorse their use.

Methods/Design

PROGUT is a randomized, placebo-controlled, double-blind, five-center, Canadian, emergency department trial. Children aged 3 months to 48 months who present between November 2013 and June 2017 with <72 hours of gastroenteritis symptoms will be assessed for eligibility. A total of 886 children will be randomized (1:1 allocation via an internet based, third party, randomization service) to receive 5 days of a combination probiotic agent (Lactobacillus rhamnosus and L. helveticus) or placebo. All participants, caregivers, and outcome assessors will be blinded to group assignment. The study includes three key outcomes: 1) clinical - the development of moderate to severe disease following an emergency department (ED) evaluation that employs a validated clinical score (Modified Vesikari Scale); 2) safety - side effect; and 3) mechanism - fecal secretory immunoglobulin A levels.

Discussion

Definitive data are lacking to guide the clinical use of probiotics in children with acute gastroenteritis. Hence, probiotics are rarely prescribed by North American physicians. However, the following current trends obligate an urgent assessment: 1) probiotics are sold as food supplements, and manufacturers can encourage their use while their relevance has yet to be established; 2) North American and European government agencies remain concerned about their value and safety; 3) some institutions are now recommending the routine use of probiotics; and 4) parents of affected children are often providing probiotics. With probiotic consumption increasing in the absence of solid evidence, there is a need to conduct this definitive trial to overcome the limitations of prior work in this field.

Trial registration

ClinicalTrials.gov: NCT01853124; first registered 9 May 2013.

Keywords:
Probiotics; Emergencies; Pediatrics; Gastroenteritis; Randomized controlled trial; Adverse effects; Immunoglobulin A