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. Trials 2014 May 14;15:170
Date
06/03/2014Pubmed ID
24885220Pubmed Central ID
PMC4037747DOI
10.1186/1745-6215-15-170Scopus ID
2-s2.0-84901625734 (requires institutional sign-in at Scopus site) 23 CitationsAbstract
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.
Author List
Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH, Pediatric Emergency Research Canada (PERC) Gastroenteritis Study GroupMESH terms used to index this publication - Major topics in bold
Acute DiseaseAge Factors
Canada
Child, Preschool
Clinical Protocols
Double-Blind Method
Emergency Service, Hospital
Gastroenteritis
Humans
Infant
Intestines
Lactobacillus helveticus
Probiotics
Research Design
Time Factors
Treatment Outcome
