Evidence map›Paper›PMID 30462939›Full record

Trial reportThe New England journal of medicine2018

Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis.

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 and 7 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01853124 (Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis), which is not on this map. Cited by 101 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 8 pooled it
18.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01853124 phase3completednot on this map

Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial

TypeinterventionalSponsorDr. Stephen FreedmanRan2013 to 2017Enrolled886ConditionsGastroenteritisArmsPlacebo, Lacidofil
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 8 syntheses or guidelines pooled it, 238 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Probiotics for treating acute infectious diarrhoea.The Cochrane database of systematic reviews · 2020
    Pooled it
  7. Guideline
  8. Pooled it
  9. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Review
  17. Article
  18. The gut as a central hub for multi-organ crosstalk in aging.Cellular and molecular life sciences : CMLS · 2026
    Review
  19. Review
  20. Article

41 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 3 countries.

Stephen B FreedmanFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).ORCID 0000-0003-2319-6192
Sarah Williamson-UrquhartFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Ken J FarionFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Serge GouinFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Andrew R WillanFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Naveen PoonaiFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Katrina HurleyFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Philip M ShermanFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Yaron FinkelsteinFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Bonita E LeeFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Xiao-Li PangFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Linda ChuiFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
David SchnadowerFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Jianling XieFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Marc GorelickFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Suzanne SchuhFrom the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
PERC PROGUT Trial Group
Alberta Children's Hospital · CAIzaak Walton Killam Health Centre · CAUniversity of Minnesota · USUniversity of Ottawa · CAWashington University in St. Louis · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGastroenteritis accounts for approximately 1.7 million visits to the emergency department (ED) by children in the United States every year. Data to determine whether the use of probiotics improves outcomes in these children are lacking.

methodsWe conducted a randomized, double-blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric EDs in Canada. Participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052, at a dose of 4.0×10

resultsModerate-to-severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants (26.1%) who were assigned to probiotics and 102 of 413 participants (24.7%) who were assigned to placebo (odds ratio, 1.06; 95% confidence interval [CI], 0.77 to 1.46; P=0.72). After adjustment for trial site, age, detection of rotavirus in stool, and frequency of diarrhea and vomiting before enrollment, trial-group assignment did not predict moderate-to-severe gastroenteritis (odds ratio, 1.06; 95% CI, 0.76 to 1.49; P=0.74). There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea (52.5 hours [interquartile range, 18.3 to 95.8] and 55.5 hours [interquartile range, 20.2 to 102.3], respectively; P=0.31) or vomiting (17.7 hours [interquartile range, 0 to 58.6] and 18.7 hours [interquartile range, 0 to 51.6], P=0.18), the percentages of participants with unscheduled visits to a health care provider (30.2% and 26.6%; odds ratio, 1.19; 95% CI, 0.87 to 1.62; P=0.27), and the percentage of participants who reported an adverse event (34.8% and 38.7%; odds ratio, 0.83; 95% CI, 0.62 to 1.11; P=0.21).

conclusionsIn children who presented to the emergency department with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment. (Funded by the Canadian Institutes of Health Research and others; PROGUT ClinicalTrials.gov number, NCT01853124 .).

Indexed as

Lacticaseibacillus rhamnosusLactobacillus helveticusAcute DiseaseChild, PreschoolDiarrheaDouble-Blind MethodFemaleGastroenteritisHumansInfantMalePatient AcuityProbioticsTreatment FailureVomiting

Identifiers

PMID30462939
OpenAlexW2901521492

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.