Clinical trial NCT00760773: Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance
Official title: Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroenteritis
Keywords: Probiotic treatment
Daycare attendance
Pediatric
Emergency department
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 132
Sex: ALL
Minimum age (years): 4
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Gastroenteritis in children utilizes significant health care resources and has a significant impact on children, caregivers and society. In the United States, gastroenteritis accounts for more than 1.5 million outpatient visits and 200,000 hospitalizations per year. Data from British Columbia indicate that gastroenteritis annually accounts for 12 million missed workdays by adults and 10 million missed school days by children in this province alone. Canadian data, including the cost of work absenteeism, report the mean annual cost/gastroenteritis case to be $1,089.

Although medications have not routinely been recommended, acute gastroenteritis in children can result in significant morbidity. Thus, physicians and caregivers desire treatment options to reduce the burden of disease. Recently, ondansetron, an antiemetic agent has been found to be effective in pediatric gastroenteritis, and is now frequently employed to reduce vomiting. Probiotics agents may represent another valuable treatment option. Since the early 1990s, research has been conducted on the effects of probiotics, defined as viable microbial preparations that have a beneficial effect on the health and well being of the host.

A recent Cochrane Database systematic review recently concluded that "probiotics appear to be a useful adjunct to rehydration therapy in treating acute, infectious diarrhea." However, the review also concluded that more research is needed to determine which specific probiotic regimens should be employed in specific patient groups. The later statement is of particular importance in North America as probiotics are not a mainstay of clinical practice. While only 18% of Canadian physicians are aware of research on probiotics, 82% feel that more probiotic research is needed, and 76% feel there is a role for probiotics in their practice. This discrepancy likely is due to the absence of probiotic trials in North American patients and because the outcome measures evaluated often have had limited clinical applicability. Since most episodes of acute diarrhea require no specific treatment, cost-effectiveness analyses are also required before the widespread use of probiotics can be endorsed.

Eligibility 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

Primary outcomes:
measure: Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
timeFrame: 2 weeks
Secondary outcomes:
measure: Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
timeFrame: 2 weeks
measure: Intravenous rehydration
timeFrame: 2 weeks
measure: Duration of diarrhea
timeFrame: Meaured by outcome
measure: Duration of vomiting
timeFrame: Meaured by outcome
measure: Number of days the child does not go to daycare.
timeFrame: Measured by outcome
measure: Work absenteeism
timeFrame: 2 weeks
measure: Economic analysis
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Hospital Sainte Justine
state: Quebec
Study officials:
affiliation: The Hospital for Sick Children
name: Stephen Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References: