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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

January 10, 2013
January 23, 2013
December 20, 2017
July 2014
December 2017   (Final data collection date for primary outcome measure)
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
  • 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
  • Severe adverse events [ Time Frame: 1 year ]
    presence of severe adverse events up to 1 year after treatment
Complete list of historical versions of study NCT01773967 on ClinicalTrials.gov Archive Site
  • Extra intestinal infection with LGG [ Time Frame: 1 month ]
    bacteremia
  • Diarrhea duration [ Time Frame: 14 days ]
    number of days
  • Vomiting duration [ Time Frame: 14 days ]
    number of days
  • Unscheduled healthcare visits [ Time Frame: 14 days ]
    number
  • Missed day care or missed work [ Time Frame: 14 days ]
    number of days
  • Household transmission rates [ Time Frame: 14 days ]
    number of individuals with new AGE symtoms in household after randomization
Not Provided
Not Provided
Not Provided
 
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroenteritis
  • Drug: LGG
    LGG 10^10 cfu PO BID X 5 days
    Other Names:
    • Lactobacillus GG ATCC 53103
    • Lactobacillus rhamnosus
    • culturelle
  • Drug: micro-crystalline cellulose
    1 capsule PO bid x 5 days
    Other Name: placebo micro-crystalline cellulose
  • Experimental: LGG
    LGG 10^10 cfu PO bid x 5 days
    Intervention: Drug: LGG
  • Placebo Comparator: Placebo
    micro-crystalline cellulose PO bid x 5 days
    Intervention: Drug: micro-crystalline cellulose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
970
900
December 2017
December 2017   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
3 Months to 48 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01773967
1R01HD071915( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
David Schnadower, Washington University School of Medicine
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
Principal Investigator: David Schnadower, MD Washington University School of Medicine
Washington University School of Medicine
December 2017

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