Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

PHASE3CompletedINTERVENTIONAL
Enrollment

886

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

Conditions
Gastroenteritis
Interventions
DRUG

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.

DRUG

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.

Trial Locations (6)

T3B 6A8

Alberta Children's Hospital, Calgary

B3K 6R8

IWK Health Centre, Halifax

N6A 5W9

Children's Hospital, London Health Sciences Center, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte Justine, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Alberta Children's Hospital

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Children's Hospital of Eastern Ontario

OTHER

collaborator

St. Justine's Hospital

OTHER

collaborator

IWK Health Centre

OTHER

collaborator

Institut Rosell Lallemand

INDUSTRY

collaborator

London Health Sciences Center, Children's Hospital

UNKNOWN

lead

Dr. Stephen Freedman

OTHER

NCT01853124 - Emergency Department Probiotic Treatment of Pediatric Gastroenteritis | Biotech Hunter | Biotech Hunter