Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial

Stephen B. Freedman, Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Yaron Finkelstein, Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Xiao Li Pang, Alberta Precision Laboratories-Public Health Laboratory, Alberta, Canada.
Linda Chui, Alberta Precision Laboratories-Public Health Laboratory, Alberta, Canada.
Phillip I. Tarr, Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
John M. VanBuren, Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
Cody Olsen, Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
Bonita E. Lee, Department of Pediatrics, University of Alberta, Women and Children's Health Research Institute, Edmonton, Alberta, Canada.
Carla A. Hall-Moore, Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
Robert Sapien, Department of Emergency Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
Karen O'Connell, Departments of Pediatrics and Emergency Medicine, The George Washington University School of Medicine and Health Sciences, Division of Emergency Medicine, Children's National Hospital, Washington D.C., USA.
Adam C. Levine, Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, Rhode Island, USA.
Naveen Poonai, Departments of Pediatrics, Internal Medicine, Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, London, Ontario, Canada.
Cindy Roskind, Department of Emergency Medicine, Columbia University Medical Center, New York, New York, USA.
Suzanne Schuh, Division of Pediatric Emergency Medicine, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Alexander Rogers, Departments of Emergency Medicine and Pediatrics. Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Seema Bhatt, Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Serge Gouin, Departments of Pediatric Emergency Medicine & Pediatrics, Université de Montréal, Montréal, Quebec, Canada.
Prashant Mahajan, Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.
Cheryl Vance, Departments of Emergency Medicine and Pediatrics, UC Davis, School of Medicine, Sacramento, California, USA.
Katrina Hurley, Department of Emergency Medicine, IWK Health, Dalhousie University, Halifax, Nova Scotia, Canada.
Elizabeth C. Powell, Department of Pediatrics, Division of Emergency Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAand.
Ken J. Farion, Departments of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Canada.
David Schnadower, Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.

Document Type

Journal Article

Publication Date

8-24-2022

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Volume

75

Issue

1

DOI

10.1093/cid/ciab876

Keywords

child; diarrhea; emergency service; gastroenteritis; hospital; probiotic

Abstract

BACKGROUND: It is unknown if probiotics exert pathogen-specific effects in children with diarrhea secondary to acute gastroenteritis. METHODS: Analysis of patient-level data from 2 multicenter randomized, placebo controlled trials conducted in pediatric emergency departments in Canada and the United States. Participants were 3-48 months with >3 diarrheal episodes in the preceding 24 hours and were symptomatic for <72 hours and <7 days in the Canadian and US studies, respectively. Participants received either placebo or a probiotic preparation (Canada-Lactobacillus rhamnosus R0011/Lactobacillus helveticus R0052; US-L. rhamnosus GG). The primary outcome was post-intervention moderate-to-severe disease (ie, ≥9 on the Modified Vesikari Scale [MVS] score). RESULTS: Pathogens were identified in specimens from 59.3% of children (928/1565). No pathogen groups were less likely to experience an MVS score ≥9 based on treatment allocation (test for interaction = 0.35). No differences between groups were identified for adenovirus (adjusted relative risk [aRR]: 1.42; 95% confidence interval [CI]: .62, 3.23), norovirus (aRR: 0.98; 95% CI: .56, 1.74), rotavirus (aRR: 0.86; 95% CI: .43, 1.71) or bacteria (aRR: 1.19; 95% CI: .41, 3.43). At pathogen-group and among individual pathogens there were no differences in diarrhea duration or the total number of diarrheal stools between treatment groups, regardless of intervention allocation or among probiotic sub-groups. Among adenovirus-infected children, those administered the L. rhamnosus R0011/L. helveticus R0052 product experienced fewer diarrheal episodes (aRR: 0.65; 95% CI: .47, .90). CONCLUSIONS: Neither probiotic product resulted in less severe disease compared to placebo across a range of the most common etiologic pathogens. The preponderance of evidence does not support the notion that there are pathogen specific benefits associated with probiotic use in children with acute gastroenteritis. CLINICAL TRIALS REGISTRATION: NCT01773967 and NCT01853124.

Department

Pediatrics

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