Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.

Inclusion criteria

• Age 3-48 months (have not yet reached their fourth birthday); AND
• Presence of 3 or more watery stools within 24 hours of screening; AND
• Duration of vomiting or diarrhea less than 7 days; AND
• Symptoms consistent with acute intestinal infectious process.

Exclusion criteria

• Presence of an indwelling vascular access line; OR
• Presence of structural heart disease excluding non-pathological heart murmurs; OR
• Receiving immunosuppressive therapy or history of immunodeficiency; OR
• Hematochezia in the preceding 48 hours; OR
• Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
• Patients with known pancreatitis; OR
• History of abdominal surgery; OR
• Critically ill patients; OR
• Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
• Bilious emesis; OR
• Probiotic use (supplement) in the preceding 2 weeks; OR
• Oral or intravenous steroid use in the preceding six months; OR
• Previously enrolled in this trial; OR
• Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
• Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
• Not available for daily follow-up while symptomatic; OR
• Parent/guardian not speaking English or Spanish; OR
• Under 6 months old AND premature (<37 weeks).