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

Results First Posted : September 6, 2019

Last Update Posted : September 6, 2019

Sponsor:

Collaborators:

Columbia University

Northwestern University

University of New Mexico

Children's National 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

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gastroenteritis	Drug: LGG Drug: micro-crystalline cellulose	Phase 2 Phase 3

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	971 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Actual Study Start Date :	July 2014
Actual Primary Completion Date :	August 2018
Actual Study Completion Date :	August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Cellulose, microcrystalline

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Number of Participants With Modified Vesikari Scale Score >=9 [ 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. Scores >=9 indicate moderate-severe gastroenteritis. Higher is worse.

Secondary Outcome Measures :

Number of Participants With LGG Bacteremia [ Time Frame: 1 month ]
bacteremia caused by LGG
Diarrhea Duration [ Time Frame: 14 days ]
diarrhea duration in hours after randomization

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773967

Locations

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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Children's Hospital of New York
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Washington University School of Medicine

Columbia University

Northwestern University

University of New Mexico

Children's National Research Institute

University of Utah

Wayne State University

Children's Hospital Medical Center, Cincinnati

University of Michigan

Brown University

University of California, Davis

Investigators

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Principal Investigator:	Kimberly Quayle, MD	Washington University School of Medicine

Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Study Protocol and Statistical Analysis Plan [PDF] April 6, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schnadower D, O'Connell KJ, VanBuren JM, Vance C, Tarr PI, Schuh S, Hurley K, Rogers AJ, Poonai N, Roskind CG, Bhatt SR, Gouin S, Mahajan P, Olsen CS, Powell EC, Farion K, Sapien RE, Chun TH, Freedman SB; Pediatric Emergency Care Applied Research Network and Pediatric Emergency Research Canada. Association Between Diarrhea Duration and Severity and Probiotic Efficacy in Children With Acute Gastroenteritis. Am J Gastroenterol. 2021 Jul 1;116(7):1523-1532. doi: 10.14309/ajg.0000000000001295.

Freedman SB, Roskind CG, Schuh S, VanBuren JM, Norris JG, Tarr PI, Hurley K, Levine AC, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Powell EC, Farion KJ, Sapien R, O'Connell K, Poonai N, Schnadower D; Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Networks. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021 Jun;147(6). pii: e2020030890. doi: 10.1542/peds.2020-030890. Epub 2021 May 20.

Poonai N, Powell EC, Schnadower D, Casper TC, Roskind CG, Olsen CS, Tarr PI, Mahajan P, Rogers AJ, Schuh S, Hurley KF, Gouin S, Vance C, Farion KJ, Sapien RE, O'Connell KJ, Levine AC, Bhatt S, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) and Pediatric Emergency Research Canada (PERC). Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Apr 1;4(4):e216433. doi: 10.1001/jamanetworkopen.2021.6433. Erratum in: JAMA Netw Open. 2021 Jun 1;4(6):e2116800.

Schnadower D, Sapien RE, Casper TC, Vance C, Tarr PI, O'Connell KJ, Levine AC, Roskind CG, Rogers AJ, Bhatt SR, Mahajan P, Powell EC, Olsen CS, Gorelick MH, Dean JM, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. J Nutr. 2021 Jan 4;151(1):65-72. doi: 10.1093/jn/nxaa313.

Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O'Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children. N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598.

Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean MJ, O'Connell KJ, Mahajan P, Chun TH, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Gao F, Freedman SB. Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol. BMJ Open. 2017 Sep 24;7(9):e018115. doi: 10.1136/bmjopen-2017-018115.

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.

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Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01773967
Obsolete Identifiers:	NCT00970164
Other Study ID Numbers:	1R01HD071915 ( U.S. NIH Grant/Contract )
First Posted:	January 23, 2013 Key Record Dates
Results First Posted:	September 6, 2019
Last Update Posted:	September 6, 2019
Last Verified:	August 2019

Keywords provided by Washington University School of Medicine:


Lactobacillus rhamnosus GG LGG Probiotic Gastroenteritis	acute gastroenteritis child pediatric RCT

Additional relevant MeSH terms:

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Gastroenteritis Emergencies Disease Attributes	Pathologic Processes Gastrointestinal Diseases Digestive System Diseases

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