title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01853124; first registered 9 May 2013.
authors.affiliation: 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. stephen.freedman@albertahealthservices.ca.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Freedman
authors.forename: Sarah
authors.initials: S
authors.lastname: Williamson-Urquhart
authors.forename: Suzanne
authors.initials: S
authors.lastname: Schuh
authors.forename: Philip M
authors.initials: PM
authors.lastname: Sherman
authors.forename: Ken J
authors.initials: KJ
authors.lastname: Farion
authors.forename: Serge
authors.initials: S
authors.lastname: Gouin
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
authors.forename: Ron
authors.initials: R
authors.lastname: Goeree
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.forename: Karen
authors.initials: K
authors.lastname: Black
authors.forename: David
authors.initials: D
authors.lastname: Schnadower
authors.forename: Marc H
authors.initials: MH
authors.lastname: Gorelick
mesh_terms: D000208:Acute Disease; D000367:Age Factors; D002170:Canada; D002675:Child, Preschool; D002985:Clinical Protocols; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005759:Gastroenteritis / Q000175:diagnosis / Q000382:microbiology / Q000628:therapy*; D006801:Humans; D007223:Infant; D007422:Intestines / Q000382:microbiology*; D052198:Lactobacillus helveticus / Q000502:physiology*; D052201:Lacticaseibacillus rhamnosus / Q000502:physiology*; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome