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Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children
David Schnadower1, Phillip I Tarr1, T Charles Casper1
1From the Divisions of Pediatric Emergency Medicine (D.S., V.P.D.) and Gastroenterology, Hepatology, and Nutrition (P.I.T., C.H.-M.), Department of Pediatrics, Washington University School of Medicine, St. Louis; the Department of Pediatrics, University of Utah, Salt Lake City (T.C.C., J.M.D., C.S.O., M.M.); Central Administration, Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis (M.H.G.); the Division of Emergency Medicine, Children's National Health System, Department of Pediatrics, George Washington School of Medicine and Health Sciences, Washington, DC (K.J.O.); the Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Michigan, Wayne State University, Detroit (P.M.); the Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor (P.M., A.J.R.); the Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence (A.C.L.); the Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (D.S., S.R.B.); the Division of Emergency Medicine, Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York (C.G.R.); the Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago (E.C.P.); the Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento (C.V.); the Department of Emergency Medicine, University of New Mexico, Albuquerque (R.E.S.); and the Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada (S.B.F.).
Background:
Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited.
Methods:
We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×1010 colony-forming units twice daily or matching placebo. Follow-up surveys were conducted daily for 5 days and again 14 days after enrollment and 1 month after enrollment. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease), within 14 days after enrollment. Secondary outcomes included the duration and frequency of diarrhea and vomiting, the duration of day-care absenteeism, and the rate of household transmission (defined as the development of symptoms of gastroenteritis in previously asymptomatic household contacts).
Results:
Among the 971 participants, 943 (97.1%) completed the trial. The median age was 1.4 years (interquartile range, 0.9 to 2.3), and 513 participants (52.9%) were male. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P=0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16).
Conclusions:
Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT01773967 .).
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