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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants.
Journal of Pediatrics 2001 March
OBJECTIVE: Nosocomial diarrhea is a major problem in pediatric hospitals worldwide. We evaluated the efficacy of orally administered Lactobacillus GG (LGG) in the prevention of this disease in young children.
STUDY DESIGN: Eighty-one children aged 1 to 36 months who were hospitalized for reasons other than diarrhea were enrolled in a double-blind trial and randomly assigned at admission to receive LGG (n = 45) at a dose of 6 x 10(9) colony-forming units or a comparable placebo (n = 36) twice daily orally for the duration of their hospital stay.
RESULTS: LGG reduced the risk of nosocomial diarrhea (> or =3 loose or watery stools/24 h) in comparison with placebo (6.7% vs 33.3%; relative risk: 0.2; [95% CI: 0.06-0.6]; number needed to treat: 4 [95% CI: 2-10]). The prevalence of rotavirus infection was similar in LGG and placebo groups (20% vs 27.8%, respectively; relative risk: 0.72; 95% CI: 0.33-1.56). However, the use of LGG compared with placebo significantly reduced the risk of rotavirus gastroenteritis (1/45 [2.2%] vs 6/36 [16.7%], respectively; relative risk: 0.13; 95% CI: 0.02-0.79; number needed to treat: 7; 95% CI: 3-40).
CONCLUSIONS: Prophylactic use of LGG significantly reduced the risk of nosocomial diarrhea in infants, particularly nosocomial rotavirus gastroenteritis.
STUDY DESIGN: Eighty-one children aged 1 to 36 months who were hospitalized for reasons other than diarrhea were enrolled in a double-blind trial and randomly assigned at admission to receive LGG (n = 45) at a dose of 6 x 10(9) colony-forming units or a comparable placebo (n = 36) twice daily orally for the duration of their hospital stay.
RESULTS: LGG reduced the risk of nosocomial diarrhea (> or =3 loose or watery stools/24 h) in comparison with placebo (6.7% vs 33.3%; relative risk: 0.2; [95% CI: 0.06-0.6]; number needed to treat: 4 [95% CI: 2-10]). The prevalence of rotavirus infection was similar in LGG and placebo groups (20% vs 27.8%, respectively; relative risk: 0.72; 95% CI: 0.33-1.56). However, the use of LGG compared with placebo significantly reduced the risk of rotavirus gastroenteritis (1/45 [2.2%] vs 6/36 [16.7%], respectively; relative risk: 0.13; 95% CI: 0.02-0.79; number needed to treat: 7; 95% CI: 3-40).
CONCLUSIONS: Prophylactic use of LGG significantly reduced the risk of nosocomial diarrhea in infants, particularly nosocomial rotavirus gastroenteritis.
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