The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
971
LGG 10\^10 cfu PO BID X 5 days
1 capsule PO bid x 5 days
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
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.
Time frame: 14 days
Number of Participants With LGG Bacteremia
bacteremia caused by LGG
Time frame: 1 month
Diarrhea Duration
diarrhea duration in hours after randomization
Time frame: 14 days
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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