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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00760773
First received: September 25, 2008
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Drug: Lacidophil (experimental high dose)
Drug: Lacidophil (experimental standard dose)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Intravenous rehydration [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Duration of diarrhea [ Time Frame: Meaured by outcome ] [ Designated as safety issue: No ]
  • Duration of vomiting [ Time Frame: Meaured by outcome ] [ Designated as safety issue: No ]
  • Number of days the child does not go to daycare. [ Time Frame: Measured by outcome ] [ Designated as safety issue: No ]
  • Work absenteeism [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Economic analysis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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.
Experimental: 2 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.
Placebo Comparator: 3 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.

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

Ages Eligible for Study:   4 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760773

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
Hospital Sainte Justine
Montreal, Quebec, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Stephen Freedman, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00760773     History of Changes
Other Study ID Numbers: 1000012686
Study First Received: September 25, 2008
Last Updated: November 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Probiotic treatment
Daycare attendance
Pediatric
Emergency department

Additional relevant MeSH terms:
Emergencies
Gastroenteritis
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014