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:

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Cellulose, microcrystalline

U.S. FDA Resources

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

Primary Outcome Measures:

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


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 (Child)
Sexes Eligible for Study:	All
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

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):

Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH; Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group.. Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. Trials. 2014 May 14;15:170. doi: 10.1186/1745-6215-15-170.


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 ( US NIH Grant/Contract Award Number )
Study First Received:	January 10, 2013
Last Updated:	December 8, 2014

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 May 23, 2017

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