Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance (NCT00760773) | Clinical Trial Compass
TerminatedPhase 2
Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance
Stopped: Funding ended and fewer than required number of patients enrolled.
Canada132 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range
4 Months – 48 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.