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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Columbia University
Northwestern University
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
ClinicalTrials.gov Identifier:
NCT01773967
First received: January 10, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Gastroenteritis
Drug: LGG
Drug: micro-crystalline cellulose
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 (LGG) Treatment of Pediatric Gastroenteritis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Modified Vesikari Score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    presence of severe adverse events up to 1 year after treatment


Estimated Enrollment: 900
Study Start Date: July 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   3 Months to 48 Months
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773967

Contacts
Contact: David Schnadower, MD 314 747 5604 schnadower_d@kids.wustl.edu
Contact: Phillip I Tarr, MD 314 286 2848 Tarr@kids.wustl.edu

Locations
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David Schnadower, MD    314-747-5604    schnadower_d@kids.wustl.edu   
Contact: Viani Dickey    (314) 286-1108    dickey_v@kids.wustl.edu   
Principal Investigator: David Schnadower, MD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Northwestern University
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
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Schnadower, Assistant Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01773967     History of Changes
Obsolete Identifiers: NCT00970164
Other Study ID Numbers: 1 R01 HD071915-02
Study First Received: January 10, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on August 26, 2014