Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment randomized controlled trialReportar como inadecuado




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Trials

, 15:170

First Online: 14 May 2014Received: 21 January 2014Accepted: 29 April 2014DOI: 10.1186-1745-6215-15-170

Cite this article as: Freedman, S.B., Williamson-Urquhart, S., Schuh, S. et al. Trials 2014 15: 170. doi:10.1186-1745-6215-15-170

Abstract

BackgroundThe 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-DesignPROGUT 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.

DiscussionDefinitive 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 registrationClinicalTrials.gov: NCT01853124; first registered 9 May 2013.

KeywordsProbiotics Emergencies Pediatrics Gastroenteritis Randomized controlled trial Adverse effects Immunoglobulin A AbbreviationsACHAlberta Children’s Hospital

AGEacute gastroenteritis

CFUcolony forming unit

CIHRCanadian Institutes for Health Research

CRICClinical Research Informatics Core

DSMCData Safety Monitoring Committee

EDemergency department

HSCHospital for Sick Children

IgAimmunoglobulin A

MVSModified Vesikari Scale

ORSoral rehydration solution

PROGUTProbiotic Regimen for Outpatient Gastroenteritis Utility of Treatment

RCTrandomized clinical Trial

REBResearch Ethics Board

SAEserious adverse event

sIgAsecretory immunoglobulin A.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-170 contains supplementary material, which is available to authorized users.

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Autor: Stephen B Freedman - Sarah Williamson-Urquhart - Suzanne Schuh - Philip M Sherman - Ken J Farion - Serge Gouin - Andrew 

Fuente: https://link.springer.com/







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