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Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Primary Purpose

Gastroenteritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LGG
micro-crystalline cellulose
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT

Eligibility Criteria

3 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UC Davis Medical Center
  • Children's National Medical Center
  • Lurie Children's Hospital
  • University of Michigan Health System
  • Children's Hospital of Michigan
  • St. Louis Children's Hospital
  • University of New Mexico
  • Children's Hospital of New York
  • Cincinnati Children's Hospital
  • Hasbro Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LGG

Placebo

Arm Description

LGG 10^10 cfu PO bid x 5 days

micro-crystalline cellulose PO bid x 5 days

Outcomes

Primary Outcome Measures

Number of Participants With Modified Vesikari Scale Score >=9
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
bacteremia caused by LGG
Diarrhea Duration
diarrhea duration in hours after randomization

Full Information

First Posted
January 10, 2013
Last Updated
August 13, 2019
Sponsor
Washington University School of Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT01773967
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
971 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LGG
Arm Type
Experimental
Arm Description
LGG 10^10 cfu PO bid x 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
micro-crystalline cellulose PO bid x 5 days
Intervention Type
Drug
Intervention Name(s)
LGG
Other Intervention Name(s)
Lactobacillus GG ATCC 53103, Lactobacillus rhamnosus, culturelle
Intervention Description
LGG 10^10 cfu PO BID X 5 days
Intervention Type
Drug
Intervention Name(s)
micro-crystalline cellulose
Other Intervention Name(s)
placebo micro-crystalline cellulose
Intervention Description
1 capsule PO bid x 5 days
Primary Outcome Measure Information:
Title
Number of Participants With Modified Vesikari Scale Score >=9
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of Participants With LGG Bacteremia
Description
bacteremia caused by LGG
Time Frame
1 month
Title
Diarrhea Duration
Description
diarrhea duration in hours after randomization
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Quayle, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Children's Hospital of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34596225
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.
Results Reference
derived
PubMed Identifier
34183579
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.
Results Reference
derived
PubMed Identifier
34016656
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.
Results Reference
derived
PubMed Identifier
33871616
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. Erratum In: JAMA Netw Open. 2021 Jun 1;4(6):e2116800.
Results Reference
derived
PubMed Identifier
33274370
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.
Results Reference
derived
PubMed Identifier
30462938
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.
Results Reference
derived
PubMed Identifier
28947466
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.
Results Reference
derived
PubMed Identifier
24885220
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.
Results Reference
derived

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Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

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