Introduction

Acute gastroenteritis affects millions of children in the U.S. every year, leading to emergency department visits and hospitalizations. Probiotics, particularly Lactobacillus rhamnosus GG (LGG), have been commonly used as a treatment, but evidence supporting their effectiveness has been limited. A new study conducted by the Pediatric Emergency Care Applied Research Network (PECARN) aimed to determine whether LGG could reduce the severity of gastroenteritis in children. The trial found that LGG did not significantly improve outcomes compared to placebo.

Why is this important for patients and caregivers?

The study clarifies that probiotics, particularly LGG, may not be as beneficial as previously thought for treating acute gastroenteritis in children.This can help caregivers make informed decisions about the use of probiotics during their child’s illness.Reducing unnecessary treatments can also reduce medical costs and the burden of administering non-beneficial interventions. Parents often use probiotics, like Lactobacillus rhamnosus GG, hoping to reduce the severity of their child’s gastroenteritis. However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. By using the latest research, parents can focus on more effective treatments like hydration.

Study question

Does administering Lactobacillus rhamnosus GG to children with acute gastroenteritis reduce the incidence of moderate-to-severe disease compared to placebo?

Study design

This randomized, double-blind, placebo-controlled trial included 971 children between the ages of 3 months and 4 years who presented to 10 U.S. emergency departments. The children received either LGG or a placebo for five days, and their symptoms were monitored for two weeks.

Results

The study found no significant difference between the LGG and placebo groups in terms of moderate-to-severe gastroenteritis (11.8% vs. 12.6%, respectively). There were also no differences in the duration of diarrhea or vomiting, day-care absenteeism, or household transmission of symptoms.

Caution

While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits.

A brief message from the principal investigator

We studied close to a thousand patients with acute gastroenteritis in ten U. S. hospitals. We found that probiotics did not improve patient outcomes when compared to placebo. We looked at every outcome we could think of, combined gastroenteritis severity score, duration and severity of diarrhea and vomiting, duration of fever, unplanned healthcare visits, household transmission rates, daycare and work absenteeism. And we also looked in every subgroup we could think of, young versus older, on and off antibiotics, viral or bacterial gastroenteritis, patients that were exclusively breastfed versus not, and the answer was always the same. There were absolutely no differences between the probiotic and the placebo groups.

David Schnadower, MD, MPH

Take Home Points

Lactobacillus rhamnosus GG does not reduce the severity or duration of gastroenteritis symptoms in children.Caregivers should prioritize hydration and symptomatic care over probiotics for managing gastroenteritis.The findings may shift the approach to treating pediatric gastroenteritis in both clinical and home settings.

References

Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O’Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children. N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598. PMID: 30462938; PMCID: PMC6358014.

Freedman et al. Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis. N Engl J Med 2018; 379:2015-2026. DOI: 10.1056/NEJMoa1802597.

Parker et al. Rapid adoption of Lactobacillus rhamnosus GG for acute gastroenteritis. Pediatrics, 2013.

Szajewska et al. Meta-analysis: Lactobacillus GG for treating acute gastroenteritis in children–updated analysis of randomised controlled trials. Aliment Pharmacol Ther. 2013 Sep;38(5):467-76. doi: 10.1111/apt.12403. Epub 2013 Jul 10.