Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol

David Schnadower, Phillip I Tarr, T Charles Casper, Marc H Gorelick, Michael J Dean, Karen J O'Connell, Prashant Mahajan, Thomas H Chun, Seema R Bhatt, Cindy G Roskind, Elizabeth C Powell, Alexander J Rogers, Cheryl Vance, Robert E Sapien, Feng Gao, Stephen B Freedman, David Schnadower, Phillip I Tarr, T Charles Casper, Marc H Gorelick, Michael J Dean, Karen J O'Connell, Prashant Mahajan, Thomas H Chun, Seema R Bhatt, Cindy G Roskind, Elizabeth C Powell, Alexander J Rogers, Cheryl Vance, Robert E Sapien, Feng Gao, Stephen B Freedman

Abstract

Introduction: Acute gastroenteritis (AGE) is a common and burdensome condition that affects millions of children worldwide each year. Currently available strategies are limited to symptomatic management, treatment and prevention of dehydration and infection control; no disease-modifying interventions exist. Probiotics, defined as live microorganisms beneficial to the host, have shown promise in improving AGE outcomes, but existing studies have sufficient limitations such that the use of probiotics cannot currently be recommended with confidence. Here we present the methods of a large, rigorous, randomised, double-blind placebo-controlled study to assess the effectiveness and side effect profile of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) in children with AGE.

Methods and analysis: The study is being conducted in 10 US paediatric emergency departments (EDs) within the federally funded Pediatric Emergency Care Applied Research Network, in accordance with current SPIRIT and CONSORT statement recommendations. We will randomise 970 children presenting to participating EDs with AGE to either 5 days of treatment with LGG (1010colony-forming unit twice a day) or placebo between July 2014 to December 2017. The main outcome is the occurrence of moderate-to-severe disease over time, as defined by the Modified Vesikari Scale. We also record adverse events and side effects related to the intervention. We will conduct intention-to-treat analyses and use an enrichment design to restore the statistical power in case the presence of a subpopulation with a substantially low treatment effect is identified.

Ethics and dissemination: Institutional review board approval has been obtained at all sites, and data and material use agreements have been established between the participating sites. The results of the trial will be published in peer-reviewed journals. A deidentified public data set will be made available after the completion of all study procedures.

Trial registration number: NCT01773967.

Keywords: Paediatric Gastroenterology.

Conflict of interest statement

Competing interests: LGG and placebo capsules were provided in kind by i-Health Inc; however, the company did not provide financial contribution to the study or to the investigators, and their employees do not have access to the study data. i-Health Inc personnel do not have any role in study design, collection management and analysis and interpretation of data nor do they have any role or authority in writing the report nor decision to submit the trial for publication.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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