Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
NCT ID: NCT01773967
Last Updated: 2019-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
971 participants
INTERVENTIONAL
2014-07-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LGG
LGG 10\^10 cfu PO bid x 5 days
LGG
LGG 10\^10 cfu PO BID X 5 days
Placebo
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose
1 capsule PO bid x 5 days
Interventions
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LGG
LGG 10\^10 cfu PO BID X 5 days
micro-crystalline cellulose
1 capsule PO bid x 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
3 Months
48 Months
ALL
No
Sponsors
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Columbia University
OTHER
Northwestern University
OTHER
University of New Mexico
OTHER
Children's National Research Institute
OTHER
University of Utah
OTHER
Wayne State University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Michigan
OTHER
Brown University
OTHER
University of California, Davis
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Kimberly Quayle, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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UC Davis Medical Center
Sacramento, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
Children's Hospital of New York
New York, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Countries
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References
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Freedman SB, Finkelstein Y, Pang XL, Chui L, Tarr PI, VanBuren JM, Olsen C, Lee BE, Hall-Moore CA, Sapien R, O'Connell K, Levine AC, Poonai N, Roskind C, Schuh S, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Hurley K, Powell EC, Farion KJ, Schnadower D. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):55-64. doi: 10.1093/cid/ciab876.
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):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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCT00970164
Identifier Type: -
Identifier Source: nct_alias
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