Public Release: 

Probiotic no better than placebo for acute gastroenteritis in children

Results of large randomized controlled trial call into question current recommendations

Ann & Robert H. Lurie Children's Hospital of Chicago

While probiotics are often used to treat acute gastroenteritis (also known as infectious diarrhea) in children, the latest evidence shows no significant differences in outcomes, compared to a placebo. These results come from the large, double-blind, randomized controlled trial conducted at 10 geographically diverse U.S. pediatric emergency departments, including Kenneth & Anne Griffin Emergency Care Center at Ann & Robert H. Lurie Children's Hospital of Chicago. Findings were published in the New England Journal of Medicine.

"This study presents the most robust evidence to date that use of probiotics does not improve outcomes of acute gastroenteritis in children, which calls into question current recommendations," says author Elizabeth Powell, MD, MPH, pediatric emergency medicine specialist at Lurie Children's and Professor of Pediatrics at Northwestern University Feinberg School of Medicine. "Recommendations to use probiotics for these patients were based on previous meta-analyses that have suggested probiotics may be beneficial, but the trials that were included had significant limitations. The rigor of our research design and our results warrant reconsideration of common practice."

Acute gastroenteritis, which can present with diarrhea, vomiting and abdominal pain, accounts for approximately 1.7 million visits to the emergency department and more than 70,000 hospitalizations per year in the U.S. It is the second leading cause of death worldwide in children younger than 5 years.

The study included 943 children, aged 3 months to 4 years of age. Two weeks after an emergency department visit for acute gastroenteritis, children in the study who received a five-day course of probiotic (Lactobacillus rhamnosus) fared no better than the placebo group in terms of illness severity, duration and frequency of diarrhea or vomiting, day-care absenteeism and rate of household transmission of the infection.

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This study was funded in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Research at Ann & Robert H. Lurie Children's Hospital of Chicago is conducted through the Stanley Manne Children's Research Institute. The Manne Research Institute is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children's is ranked as one of the nation's top children's hospitals in the U.S.News & World Report. It is the pediatric training ground for Northwestern University Feinberg School of Medicine. Last year, the hospital served more than 212,000 children from 49 states and 51 countries.

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