886
Participants
Start Date
November 30, 2013
Primary Completion Date
May 31, 2017
Study Completion Date
May 31, 2017
Placebo
All patients in this arm of the study will take 1 sachet containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid) twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total of 2 sachets per day for 5 days.
Lacidofil
All patients in this arm of the study will take 1 sachet twice daily for 5 days. Each sachet will contain a minimum of 4 billion colony-forming units (CFU) of Lactobacillus rhamnosus Rosell-11 (95%) and L. helveticus Rosell-52 (5%). The total weight of all ingredients is 1 gm. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total daily dose = 8 billion CFU x 5 days.
Alberta Children's Hospital, Calgary
IWK Health Centre, Halifax
Children's Hospital, London Health Sciences Center, London
Children's Hospital of Eastern Ontario, Ottawa
The Hospital for Sick Children, Toronto
Centre Hospitalier Universitaire Sainte Justine, Montreal
Collaborators (1)
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Alberta Children's Hospital
OTHER
The Hospital for Sick Children
OTHER
Children's Hospital of Eastern Ontario
OTHER
St. Justine's Hospital
OTHER
IWK Health Centre
OTHER
Institut Rosell Lallemand
INDUSTRY
London Health Sciences Center, Children's Hospital
UNKNOWN
Dr. Stephen Freedman
OTHER