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Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

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ClinicalTrials.gov Identifier: NCT01773967
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Columbia University
Northwestern University
University of New Mexico
Children's Research Institute
University of Utah
Wayne State University
Children's Hospital Medical Center, Cincinnati
University of Michigan
Brown University
University of California, Davis
Information provided by (Responsible Party):
David Schnadower, Washington University School of Medicine

Brief Summary:
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: LGG Drug: micro-crystalline cellulose Phase 2 Phase 3

Detailed Description:
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: LGG
LGG 10^10 cfu PO bid x 5 days
Drug: LGG
LGG 10^10 cfu PO BID X 5 days
Other Names:
  • Lactobacillus GG ATCC 53103
  • Lactobacillus rhamnosus
  • culturelle
Placebo Comparator: Placebo
micro-crystalline cellulose PO bid x 5 days
Drug: micro-crystalline cellulose
1 capsule PO bid x 5 days
Other Name: placebo micro-crystalline cellulose



Primary Outcome Measures :
  1. Modified Vesikari Score [ Time Frame: 14 days ]
    This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources


Secondary Outcome Measures :
  1. Extra intestinal infection with LGG [ Time Frame: 1 month ]
    bacteremia

  2. Diarrhea duration [ Time Frame: 14 days ]
    number of days

  3. Vomiting duration [ Time Frame: 14 days ]
    number of days

  4. Unscheduled healthcare visits [ Time Frame: 14 days ]
    number

  5. Missed day care or missed work [ Time Frame: 14 days ]
    number of days

  6. Household transmission rates [ Time Frame: 14 days ]
    number of individuals with new AGE symtoms in household after randomization



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Ages Eligible for Study:   3 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 3-48 months (have not yet reached their fourth birthday); AND
  2. Presence of 3 or more watery stools within 24 hours of screening; AND
  3. Duration of vomiting or diarrhea less than 7 days; AND
  4. Symptoms consistent with acute intestinal infectious process.

Exclusion Criteria:

  1. Presence of an indwelling vascular access line; OR
  2. Presence of structural heart disease excluding non-pathological heart murmurs; OR
  3. Receiving immunosuppressive therapy or history of immunodeficiency; OR
  4. Hematochezia in the preceding 48 hours; OR
  5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
  6. Patients with known pancreatitis; OR
  7. History of abdominal surgery; OR
  8. Critically ill patients; OR
  9. Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
  10. Bilious emesis; OR
  11. Probiotic use (supplement) in the preceding 2 weeks; OR
  12. Oral or intravenous steroid use in the preceding six months; OR
  13. Previously enrolled in this trial; OR
  14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
  15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
  16. Not available for daily follow-up while symptomatic; OR
  17. Parent/guardian not speaking English or Spanish; OR
  18. Under 6 months old AND premature (<37 weeks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773967


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Children's Hospital of New York
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Northwestern University
University of New Mexico
Children's Research Institute
University of Utah
Wayne State University
Children's Hospital Medical Center, Cincinnati
University of Michigan
Brown University
University of California, Davis
Investigators
Principal Investigator: David Schnadower, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Schnadower, Associate Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01773967     History of Changes
Obsolete Identifiers: NCT00970164
Other Study ID Numbers: 1R01HD071915 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by David Schnadower, Washington University School of Medicine:
Lactobacillus rhamnosus GG
LGG
Probiotic
Gastroenteritis
acute gastroenteritis
child
pediatric
RCT

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