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

September 1, 2009
May 17, 2011
December 2012
July 2014   (final data collection date for primary outcome measure)
Moderate to severe disease using modified Vesikari score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00970164 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis
Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroenteritis
  • Child
  • 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%).
  • Dietary Supplement: placebo
    1 sachet daily containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid)
  • Placebo Comparator: Placebo
    placebo sachet containing inactive ingredients
    Intervention: Dietary Supplement: placebo
  • Experimental: Lacidofil
    Intervention: Dietary Supplement: Lacidofil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1600
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
3 Months to 48 Months
No
Contact: Marc H Gorelick, MD 414-266-2625 mgorelic@mcw.edu
Contact: Stephen Freedman, MD 416-813-7654 ext 2382 stephen.freedman@sickkids.ca
United States,   Canada
 
NCT00970164
GorelickM-probiotic1
Not Provided
Marc H. Gorelick, MD, Medical College of Wisconsin
Washington University School of Medicine
Not Provided
Principal Investigator: Marc H Gorelick, MD Medical College of Wisconsin
Principal Investigator: Stephen Freedman, MD The Hospital for Sick Children
Washington University School of Medicine
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP