Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children

Criteria

Inclusion Criteria:

• Acute gastroenteritis as determined by the supervising physician.

• Attend daycare

• Presence of diarrhea.

• Duration of vomiting or diarrhea less than 96 hours.

• Age greater than 90 days

• Age less than 48 months

Exclusion Criteria:

• Presence of an indwelling vascular access line or congenital heart disease.

• Taking immunosuppressive therapy or history of immunodeficiency (including all primary, secondary and acquired states)

• Have recently had cardiac, oral or gastrointestinal surgery

• Pancreatic dysfunction or bloody diarrhea

• History of: hematochezia, underlying chronic gastrointestinal problem, short bowel syndrome or inflammatory bowel disease

• Family member with an indwelling vascular access line, on immunosuppressive therapy or with a known immunodeficiency

• Undergoing radiation therapy

• Exclusively breastfed

• Bilious or bloody vomitus

• Previously enrolled in this trial

• Inability to speak or read English