Status:
COMPLETED
Emergency Department Probiotic Treatment of Pediatric Gastroenteritis
Lead Sponsor:
Dr. Stephen Freedman
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
Conditions:
Gastroenteritis
Eligibility:
All Genders
3-48 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine for previously healthy children who present to a Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the digestive tra...
Detailed Description
The burden of acute gastroenteritis (AGE) on children and their families continues to be enormous. It accounts for 1.7 million pediatric emergency department (ED) visits annually in the United States ...
Eligibility Criteria
Inclusion
- Presence of diarrhea: defined as ≥ 3 watery stools in a 24-hour period
- Duration of vomiting and/or diarrhea \< 72 hours
- Age 3 to \< 48 months
Exclusion
- Presence of an indwelling vascular access line or structural heart disease
- Taking immunosuppressive therapy, or known history of immunodeficiency
- Hematochezia in the preceding 72 hours, underlying significant chronic gastrointestinal problem or inflammatory bowel disease
- Family member with an indwelling vascular access line, on immunosuppressive therapy, or with a known immunodeficiency
- Bilious vomiting
- Probiotic use (supplement) in the preceding 2 weeks
- Previously enrolled in this trial
- Daily follow-up not possible
- Allergy to Soy
- Pre-existing (known) pancreatic dysfunction or insufficiency
- Oral or Gastrointestinal surgery within preceding 7 days
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
886 Patients enrolled
Trial Details
Trial ID
NCT01853124
Start Date
November 1 2013
End Date
May 1 2017
Last Update
March 2 2018
Active Locations (6)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
3
Children's Hospital, London Health Sciences Center
London, Ontario, Canada, N6A 5W9
4
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1