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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 : February 25, 2019
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):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 10, 2013
First Posted Date  ICMJE January 23, 2013
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • 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
Change History Complete list of historical versions of study NCT01773967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Official Title  ICMJE Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Brief Summary The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastroenteritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2017)
970
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
900
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01773967
Other Study ID Numbers  ICMJE 1R01HD071915( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Kimberly Quayle, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2019

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