Grant: Operating Grant

Background: In Canada, gastroenteritis results in nearly 240,000 emergency department visits by children each year. Children seen in emergency departments often develop moderate to severe disease following their evaluation. This may include having prolonged symptoms resulting in an inability to attend daycare and for their caregivers to return to work. Because the vast majority of cases are caused by organisms against which antibiotics are ineffective, medications are not routinely recommended; however, a new option has emerged. Probiotics, which are live bacteria that have a beneficial effect on the health of the host, have demonstrated promise in recent trials in hospitalized children. Positive findings include the ability to reduce the durations of diarrhea and hospitalization. Because of a paucity of strong evidence, particularly from developed countries and outpatient settings, at present, probiotics are rarely used in clinical practice. Study Design: We propose to conduct the first multicentre, North American, emergency department clinical trial of probiotic therapy in children with gastroenteritis. Employing Canada's largest pediatric emergency medicine research network, Pediatric Emergency Research Canada, and five geographically diverse pediatric emergency departments, 886 children will be randomly assigned to receive a probiotic powder or placebo twice daily for five days. Objectives: We will answer four questions: 1-does providing a probiotic agent to children reduce the severity of disease; 2-what side effects occur when a short course of probiotics are provided; 3-how do probiotics work in children with gastroenteritis; 4-is probiotic use cost-effective. Significance: Together, these outcomes will address all the important questions regarding probiotic use in this population - clinical effectiveness, safety, mechanism of action, and economic benefit.