TY - JOUR
T1 - Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis
T2 - The PECARN probiotic study protocol
AU - Schnadower, David
AU - Tarr, Phillip I.
AU - Charles, Casper T.
AU - Gorelick, Marc H.
AU - Dean, Michael J.
AU - O'Connell, Karen J.
AU - Mahajan, Prashant
AU - Chun, Thomas H.
AU - Bhatt, Seema R.
AU - Roskind, Cindy G.
AU - Powell, Elizabeth C.
AU - Rogers, Alexander J.
AU - Vance, Cheryl
AU - Sapien, Robert E.
AU - Gao, Feng
AU - Freedman, Stephen B.
N1 - Funding Information:
Funding This work is supported by NICHD grant number R01HD071915. The Pediatric Emergency Care Applied Research Network is supported by the Health Resources and Services Administration, Maternal and Child Health Bureau, Emergency Medical Services for Children Program through the following cooperative agreements: U03MC00001, U03MC00003, U03MC00006, U03MC00007, U03MC00008, U03MC22684 and U03MC22685. Dr SF is supported by the Alberta Children’s Hospital Foundation Professorship in Child Health and Wellness. Dr PIT is supported by the Washington University Digestive Diseases Research Core Center (P30DK052574). Study sponsors 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.
Publisher Copyright:
© 2017 Article author(s).
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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 (10 10 colony-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.
AB - 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 (10 10 colony-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.
KW - Paediatric Gastroenterology
UR - http://www.scopus.com/inward/record.url?scp=85029837409&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-018115
DO - 10.1136/bmjopen-2017-018115
M3 - Article
C2 - 28947466
AN - SCOPUS:85029837409
SN - 2044-6055
VL - 7
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e018115
ER -