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

The Hospital for Sick Children

Status and phase

Terminated

Phase 2

Conditions

Gastroenteritis

Treatments

Drug: Lacidophil (experimental high dose)

Drug: Lacidophil (experimental standard dose)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00760773

1000012686

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

4 to 48 months old

Volunteers

No Healthy Volunteers

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