Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Stephen Freedman; Sarah Williamson-Urquhart
• Collaborators: 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

Criteria

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