Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

This study is not yet open for participant recruitment.
Verified May 2011 by Washington University School of Medicine
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00970164
First received: September 1, 2009
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to determine whether administration of a probiotic agent (Lacidofil) is effective in reducing the severity of acute infectious gastroenteritis among children evaluated in North American emergency departments.


Condition Intervention Phase
Gastroenteritis
Child
Dietary Supplement: Lacidofil
Dietary Supplement: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Moderate to severe disease using modified Vesikari score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of diarrhea [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Return for unscheduled care to a health care provider [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Number of days of caregiver work or school missed [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo sachet containing inactive ingredients
Dietary Supplement: placebo
1 sachet daily containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid)
Experimental: Lacidofil Dietary Supplement: Lacidofil
1 sachet by mouth daily, containing 2 billion colony-forming units of Lactobacillus rhamnosus Rosell-11 (95%) and L. helveticus Rosell-52 (5%).

  Eligibility

Ages Eligible for Study:   3 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 3-48 months
  • diarrhea (3 or more watery stools in a 24-hour period) for 2 days or less
  • evaluated in a participating emergency department in US or Canada
  • diagnosis of acute gastroenteritis by treating physicians

Exclusion Criteria:

  • patient or household member with immunodeficiency or immunosuppressive therapy
  • hematochezia in the preceding 48 hours
  • patient or household member with indwelling vascular access line
  • bilious vomiting or other signs of intestinal obstruction
  • probiotic use in the preceding 2 weeks
  • cow's milk protein allergy
  • follow-up not possible
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970164

Contacts
Contact: Marc H Gorelick, MD 414-266-2625 mgorelic@mcw.edu
Contact: Stephen Freedman, MD 416-813-7654 ext 2382 stephen.freedman@sickkids.ca

Locations
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States
United States, Illinois
Children's Memorial Hospital Not yet recruiting
Chicago, Illinois, United States
Principal Investigator: Elizabeth Powell, MD         
United States, New York
Morgan Stanley Children's Hospital of New York Not yet recruiting
New York, New York, United States
United States, Wisconsin
Children's Hospital of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53201
Principal Investigator: Marc H Gorelick, MD         
Canada, Alberta
Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada
Principal Investigator: David Johnson, MD         
Canada, Ontario
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada
Principal Investigator: Ken Farion, MD         
Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G1XB
Principal Investigator: Stephen Freedman, MD         
Canada, Quebec
Hopital Ste-Justine Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Serge Gouin, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Marc H Gorelick, MD Medical College of Wisconsin
Principal Investigator: Stephen Freedman, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Marc H. Gorelick, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00970164     History of Changes
Other Study ID Numbers: GorelickM-probiotic1
Study First Received: September 1, 2009
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
gastroenteritis
diarrhea
Lactobacillus
probiotic
child

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

ClinicalTrials.gov processed this record on April 22, 2014