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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastroenteritis
Interventions Drug: LGG
Drug: micro-crystalline cellulose
Enrollment 971
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactobacillus Rhamnosus GG Placebo
Hide Arm/Group Description

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

Period Title: Overall Study
Started 483 488
Completed 468 475
Not Completed 15 13
Reason Not Completed
Lost to Follow-up             15             13
Arm/Group Title Lactobacillus Rhamnosus GG Placebo Total
Hide Arm/Group Description

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

Total of all reporting groups
Overall Number of Baseline Participants 483 488 971
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 483 participants 488 participants 971 participants
1.4
(0.9 to 2.4)
1.4
(0.8 to 2.3)
1.4
(0.9 to 2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 488 participants 971 participants
Female
236
  48.9%
222
  45.5%
458
  47.2%
Male
247
  51.1%
266
  54.5%
513
  52.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 488 participants 971 participants
American Indian or Alaska Native
9
   1.9%
0
   0.0%
9
   0.9%
Asian
8
   1.7%
6
   1.2%
14
   1.4%
Native Hawaiian or Other Pacific Islander
1
   0.2%
3
   0.6%
4
   0.4%
Black or African American
176
  36.4%
162
  33.2%
338
  34.8%
White
144
  29.8%
163
  33.4%
307
  31.6%
More than one race
24
   5.0%
16
   3.3%
40
   4.1%
Unknown or Not Reported
121
  25.1%
138
  28.3%
259
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 483 participants 488 participants 971 participants
483 488 971
Median Modified Vesikari Scale score at presentation   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 483 participants 488 participants 971 participants
12
(10 to 14)
12
(9 to 14)
12
(10 to 14)
[1]
Measure Description: The modified Vesikari scale is a validated global gastroenteritis severity scale that includes duration and severity of vomiting and diarrhea, maximum recorded temperature, unscheduled health care visits and types of treatment received. Scores range from 0 to 20, with higher scores indicating more severe disease). A score of 9 or greater is considred moderate to severe gastroenteritis
1.Primary Outcome
Title Number of Participants With Modified Vesikari Scale Score >=9
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Rhamnosus GG Placebo
Hide Arm/Group Description:

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

Overall Number of Participants Analyzed 468 475
Measure Type: Count of Participants
Unit of Measure: Participants
55
  11.8%
60
  12.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactobacillus Rhamnosus GG, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With LGG Bacteremia
Hide Description bacteremia caused by LGG
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Rhamnosus GG Placebo
Hide Arm/Group Description:

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

Overall Number of Participants Analyzed 468 475
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Diarrhea Duration
Hide Description diarrhea duration in hours after randomization
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Rhamnosus GG Placebo
Hide Arm/Group Description:

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

Overall Number of Participants Analyzed 468 475
Median (Inter-Quartile Range)
Unit of Measure: hours
49.7
(18.8 to 86.4)
50.9
(25.0 to 88.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactobacillus Rhamnosus GG, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Van Elteren's modification Mann-Whitney
Comments [Not Specified]
Time Frame 35 days, long term follow up 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactobacillus Rhamnosus GG Placebo
Hide Arm/Group Description

LGG 10^10 cfu PO bid x 5 days

LGG: LGG 10^10 cfu PO BID X 5 days

micro-crystalline cellulose PO bid x 5 days

micro-crystalline cellulose: 1 capsule PO bid x 5 days

All-Cause Mortality
Lactobacillus Rhamnosus GG Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/483 (0.00%)      0/488 (0.00%)    
Hide Serious Adverse Events
Lactobacillus Rhamnosus GG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/483 (1.66%)      13/488 (2.66%)    
Gastrointestinal disorders     
Worsening diarrhea   3/483 (0.62%)  3 4/488 (0.82%)  4
ileus   1/483 (0.21%)  1 1/488 (0.20%)  1
dehydration   1/483 (0.21%)  1 2/488 (0.41%)  2
vomiting   0/483 (0.00%)  0 1/488 (0.20%)  1
General disorders     
fever   0/483 (0.00%)  0 1/488 (0.20%)  1
Metabolism and nutrition disorders     
metabolic acidosis   1/483 (0.21%)  1 0/488 (0.00%)  0
Nervous system disorders     
seizure  [1]  1/483 (0.21%)  1 1/488 (0.20%)  1
lethargy   1/483 (0.21%)  1 1/488 (0.20%)  1
Respiratory, thoracic and mediastinal disorders     
lower respiratory infection   0/483 (0.00%)  0 2/488 (0.41%)  2
Indicates events were collected by systematic assessment
[1]
febrile
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactobacillus Rhamnosus GG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/483 (11.39%)      49/488 (10.04%)    
Gastrointestinal disorders     
other   40/483 (8.28%)  40 35/488 (7.17%)  35
Respiratory, thoracic and mediastinal disorders     
other   15/483 (3.11%)  15 14/488 (2.87%)  14
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Schnadower
Organization: Cincinnati Children's Hospital Medical Center
Phone: 5138035526
EMail: david.schnadower@cchmc.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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 Submitted: January 10, 2013
First Posted: January 23, 2013
Results First Submitted: June 25, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019