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

NCT ID: NCT00760773

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-03-31

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.

Conditions

Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

Lacidophil (experimental high dose)

Intervention Type: DRUG

Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days.

2

Group Type: EXPERIMENTAL

Lacidophil (experimental standard dose)

Intervention Type: DRUG

Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days.

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated.

Interventions

Lacidophil (experimental high dose)

Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days.

Intervention Type: DRUG

Lacidophil (experimental standard dose)

Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days.

Intervention Type: DRUG

Placebo

The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated.

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stephen Freedman

Adjunct Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Hospital Sainte Justine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

1000012686

Identifier Type: -

Identifier Source: org_study_id