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:
Washington University School of Medicine
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
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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 May 19, 2013