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

NCT00760773 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Stephen Freedman, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-09-30
Completion
2014-03-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760773 on ClinicalTrials.gov