Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Collaborators:
Columbia University
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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: December 8, 2014
Last verified: December 2014
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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:
|
|
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 (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 3-48 months (have not yet reached their fourth birthday); AND
- Presence of 3 or more watery stools within 24 hours of screening; AND
- Duration of vomiting or diarrhea less than 7 days; AND
- Symptoms consistent with acute intestinal infectious process.
Exclusion Criteria:
- Presence of an indwelling vascular access line; OR
- Presence of structural heart disease excluding non-pathological heart murmurs; OR
- Receiving immunosuppressive therapy or history of immunodeficiency; OR
- Hematochezia in the preceding 48 hours; OR
- Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
- Patients with known pancreatitis; OR
- History of abdominal surgery; OR
- Critically ill patients; OR
- Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
- Bilious emesis; OR
- Probiotic use (supplement) in the preceding 2 weeks; OR
- Oral or intravenous steroid use in the preceding six months; OR
- Previously enrolled in this trial; OR
- Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
- Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
- Not available for daily follow-up while symptomatic; OR
- Parent/guardian not speaking English or Spanish; OR
- 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
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, California | |
| UC Davis Medical Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Cheryl Vance, MD cheryl.vance@ucdmc@ucdavis.edu | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Karen O'Connell, MD Koconnel@cnmc.org | |
| United States, Illinois | |
| Lurie Children's Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Elizabeth Powell, MD epowell@luriechildrens.org | |
| United States, Michigan | |
| University of Michigan Health System | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Alex Rogers, MD alexroge@med.umich.edu | |
| Children's Hospital of Michigan | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Prashant Mahajan, MD pmahajan@med.wayne.edu | |
| 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 | |
| United States, New York | |
| Children's Hospital of New York | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Cindy G Roskind, MD cg278@columbia.edu | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Seema Bhatt, MD 513-803-2980 seema.bhatt@cchmc.org | |
| Principal Investigator: Seema Bhatt, MD | |
| United States, Rhode Island | |
| Hasbro Children's Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Thomas Chun, MD thomas_chun@brown.edu | |
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
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: | 1R01HD071915-02 |
| Study First Received: | January 10, 2013 |
| Last Updated: | December 8, 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 September 23, 2016