Gastroenteritis Clinical Trial
Official title:
Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial
Verified date | February 2018 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 tract); if compared with placebo, the administration of a probiotic agent (Lacidofil) will result in a significantly lower proportion of children developing moderate to severe disease over the subsequent 2 weeks and will not be associated with a significantly greater occurrence of side effects.
Status | Completed |
Enrollment | 886 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 48 Months |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | Children's Hospital, London Health Sciences Center | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte Justine | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Stephen Freedman | Alberta Children's Hospital, Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario, Institut Rosell Lallemand, IWK Health Centre, London Health Sciences Center, Children's Hospital, St. Justine's Hospital, The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side Effect Profile | Determine if short course probiotic administration to young children with acute gastroenteritis is associated with an increase in minor side effects | Daily for 14 days | |
Other | Mechanism of Action | Determine if probiotic administration increases fecal secretory IgA levels in children with acute gastroenteritis | 28 Days | |
Other | Pathogen Load Quantification | 5 Days | Determine if a 5-day probiotic treatment course administered to children with acute gastroenteritis results in pathogen-specific reductions in stool pathogen load | |
Primary | Development of moderate to severe disease in the 2 weeks after the index visit | Measured daily for 14 days | ||
Secondary | Duration of Diarrhea | Daily for 14 days | ||
Secondary | Duration of Vomiting | Daily for 14 days | ||
Secondary | Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal, within two weeks | Daily for 14 days | ||
Secondary | Work and Daycare Absenteeism | Daily for 14 days |
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