David Schnadower1, Karen J O'Connell2, John M VanBuren3, Cheryl Vance4, Phillip I Tarr5, Suzanne Schuh6, Katrina Hurley7, Alexander J Rogers8, Naveen Poonai9, Cindy G Roskind10, Seema R Bhatt1, Serge Gouin11, Prashant Mahajan8, Cody S Olsen3, Elizabeth C Powell12, Ken Farion13, Robert E Sapien14, Thomas H Chun15, Stephen B Freedman16. 1. Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. 2. Division of Emergency Medicine, Children's National Hospital, Department of Pediatrics and Emergency Medicine, The George Washington School of Medicine and Health Sciences, Washington, DC, USA. 3. Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. 4. Departments of Emergency Medicine and Pediatrics, University of California, Davis, School of Medicine, Sacramento, California, USA. 5. Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA. 6. Division of Pediatric Emergency Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto and Research Institute, Toronto, Ontario, Canada. 7. Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada. 8. Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, Michigan, USA. 9. Department of Pediatrics, Schulich School of Medicine and Dentistry, and Children's Health Research Institute, London Health Sciences Centre, London, Canada. 10. Division of Emergency Medicine, Department of Pediatrics, Columbia University College of Physicians & Surgeons, New York, New York, USA. 11. Department of Pediatric Emergency Medicine, Centre Hopital Universitaire (CHU) Ste-Justine, Université de Montréal, Montreal, Quebec, Canada. 12. Division of Emergency Medicine, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. 13. Departments of Pediatrics and Emergency Medicine, University of Ottawa, and Children's Hospital of Eastern Ontario (CHEO) Research Institute, Ottawa, Ontario, Canada. 14. Department of Emergency Medicine, University of New Mexico, Albuquerque, New Mexico, USA. 15. Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, Rhode Island, USA. 16. Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Abstract
INTRODUCTION: It is unclear whether the alleged efficacy of probiotics in childhood acute gastroenteritis depends on the duration and severity of symptoms before treatment. METHODS: Preplanned secondary analysis of 2 randomized placebo-controlled trials in children 3-48 months of age was conducted in 16 emergency departments in North America evaluating the efficacy of 2 probiotic products (Lactobacillus rhamnosus GG and a combination probiotic: L. rhamnosus and L. helveticus). Participants were categorized in severity groups according to the duration (<24, 24-<72, and ≥72 hours) and the frequency of diarrhea episodes in the 24 hours (≤3, 4-5, and ≥6) before presentation. We used regression models to assess the interaction between pretreatment diarrhea severity groups and treatment arm (probiotic or placebo) in the presence of moderate-to-severe gastroenteritis (Modified Vesikari Scale score ≥9). Secondary outcomes included diarrhea frequency and duration, unscheduled healthcare provider visits, and hospitalization. RESULTS: A total of 1,770 children were included, and 882 (50%) received a probiotic. The development of moderate-to-severe gastroenteritis symptoms after the initiation of treatment did not differ between groups (probiotic-18.4% [162/882] vs placebo-18.3% [162/888]; risk ratio 1.00; 95% confidence interval 0.87, 1.16; P = 0.95). There was no evidence of interaction between baseline severity and treatment (P = 0.61) for the primary or any of the secondary outcomes: diarrhea duration (P = 0.88), maximum diarrheal episodes in a 24-hour period (P = 0.87), unscheduled healthcare visits (P = 0.21), and hospitalization (P = 0.87). DISCUSSION: In children 3-48 months with acute gastroenteritis, the lack of effect of probiotics is not explained by the duration of symptoms or frequency of diarrheal episodes before presentation.
INTRODUCTION: It is unclear whether the alleged efficacy of probiotics in childhood acute gastroenteritis depends on the duration and severity of symptoms before treatment. METHODS: Preplanned secondary analysis of 2 randomized placebo-controlled trials in children 3-48 months of age was conducted in 16 emergency departments in North America evaluating the efficacy of 2 probiotic products (Lactobacillus rhamnosus GG and a combination probiotic: L. rhamnosus and L. helveticus). Participants were categorized in severity groups according to the duration (<24, 24-<72, and ≥72 hours) and the frequency of diarrhea episodes in the 24 hours (≤3, 4-5, and ≥6) before presentation. We used regression models to assess the interaction between pretreatment diarrhea severity groups and treatment arm (probiotic or placebo) in the presence of moderate-to-severe gastroenteritis (Modified Vesikari Scale score ≥9). Secondary outcomes included diarrhea frequency and duration, unscheduled healthcare provider visits, and hospitalization. RESULTS: A total of 1,770 children were included, and 882 (50%) received a probiotic. The development of moderate-to-severe gastroenteritis symptoms after the initiation of treatment did not differ between groups (probiotic-18.4% [162/882] vs placebo-18.3% [162/888]; risk ratio 1.00; 95% confidence interval 0.87, 1.16; P = 0.95). There was no evidence of interaction between baseline severity and treatment (P = 0.61) for the primary or any of the secondary outcomes: diarrhea duration (P = 0.88), maximum diarrheal episodes in a 24-hour period (P = 0.87), unscheduled healthcare visits (P = 0.21), and hospitalization (P = 0.87). DISCUSSION: In children 3-48 months with acute gastroenteritis, the lack of effect of probiotics is not explained by the duration of symptoms or frequency of diarrheal episodes before presentation.
Authors: Stephen B Freedman; Sarah Williamson-Urquhart; Ken J Farion; Serge Gouin; Andrew R Willan; Naveen Poonai; Katrina Hurley; Philip M Sherman; Yaron Finkelstein; Bonita E Lee; Xiao-Li Pang; Linda Chui; David Schnadower; Jianling Xie; Marc Gorelick; Suzanne Schuh Journal: N Engl J Med Date: 2018-11-22 Impact factor: 91.245
Authors: Stephen B Freedman; Yaron Finkelstein; Xiao Li Pang; Linda Chui; Phillip I Tarr; John M VanBuren; Cody Olsen; Bonita E Lee; Carla A Hall-Moore; Robert Sapien; Karen O'Connell; Adam C Levine; Naveen Poonai; Cindy Roskind; Suzanne Schuh; Alexander Rogers; Seema Bhatt; Serge Gouin; Prashant Mahajan; Cheryl Vance; Katrina Hurley; Elizabeth C Powell; Ken J Farion; David Schnadower Journal: Clin Infect Dis Date: 2022-08-24 Impact factor: 20.999