Clinical trial NCT01773967: Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Official title: Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastroenteritis
Keywords: Lactobacillus rhamnosus GG
LGG
Probiotic
Gastroenteritis
acute gastroenteritis
child
pediatric
RCT
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Northwestern University
name: University of New Mexico
name: Children's National Research Institute
name: University of Utah
name: Wayne State University
name: Children's Hospital Medical Center, Cincinnati
name: University of Michigan
name: Brown University
name: University of California, Davis
First posted: 2013-01-23
Enrollment: 971
Sex: ALL
Minimum age (years): 3
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Modified Vesikari Scale Score >=9
timeFrame: 14 days
Secondary outcomes:
measure: Number of Participants With LGG Bacteremia
timeFrame: 1 month
measure: Diarrhea Duration
timeFrame: 14 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Children's Hospital of New York
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Washington University School of Medicine
name: Kimberly Quayle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.