OBJECTIVE: The purpose of this study was to evaluate the effectiveness of the probiotic Lactobacillus GG (LGG) in reducing the duration of acute infectious diarrhea in the pediatric emergency department. METHODS: We conducted a double-blind, randomized controlled trial of children 6 months to 6 years presenting to the pediatric emergency department with a complaint of diarrhea. Patients were randomized to receive either placebo or LGG powder twice daily for 5 days. With each dose, parents recorded the stool history in a home diary and were followed up daily by a blinded researcher. Groups were compared in terms of time to normal stool and number of diarrheal stools. RESULTS: Of 155 patients enrolled, 129 completed the study: 63 in the LGG group and 66 in the placebo group. There was no significant difference in the median (interquartile range) time to normal stool (LGG: 60 hours [37-111] vs placebo: 74 hours [43-120]; P = 0.37) or the number of diarrheal stools (LGG: 5.0 [1-10] vs placebo: 6.5 [2-14]; P = 0.19). Among children who presented with more than 2 days of diarrhea, the LGG group returned to normal stool earlier (LGG: 51 hours [32-78] vs placebo: 74 hours [45-120]; P = 0.02), had fewer episodes of diarrheal stools (LGG: 3.5 [1.0-7.5] vs placebo: 7 [3.0-16.3]; P = 0.02), and were 2.2 times more likely to return to normal stool (95% confidence interval, 1.3-3.9; P = 0.01) compared with children in the placebo group. CONCLUSIONS:Lactobacillus GG may reduce the duration of acute diarrheal illness among children presenting with more than 2 days of symptoms.
RCT Entities:
OBJECTIVE: The purpose of this study was to evaluate the effectiveness of the probiotic Lactobacillus GG (LGG) in reducing the duration of acute infectious diarrhea in the pediatric emergency department. METHODS: We conducted a double-blind, randomized controlled trial of children 6 months to 6 years presenting to the pediatric emergency department with a complaint of diarrhea. Patients were randomized to receive either placebo or LGG powder twice daily for 5 days. With each dose, parents recorded the stool history in a home diary and were followed up daily by a blinded researcher. Groups were compared in terms of time to normal stool and number of diarrheal stools. RESULTS: Of 155 patients enrolled, 129 completed the study: 63 in the LGG group and 66 in the placebo group. There was no significant difference in the median (interquartile range) time to normal stool (LGG: 60 hours [37-111] vs placebo: 74 hours [43-120]; P = 0.37) or the number of diarrheal stools (LGG: 5.0 [1-10] vs placebo: 6.5 [2-14]; P = 0.19). Among children who presented with more than 2 days of diarrhea, the LGG group returned to normal stool earlier (LGG: 51 hours [32-78] vs placebo: 74 hours [45-120]; P = 0.02), had fewer episodes of diarrheal stools (LGG: 3.5 [1.0-7.5] vs placebo: 7 [3.0-16.3]; P = 0.02), and were 2.2 times more likely to return to normal stool (95% confidence interval, 1.3-3.9; P = 0.01) compared with children in the placebo group. CONCLUSIONS: Lactobacillus GG may reduce the duration of acute diarrheal illness among children presenting with more than 2 days of symptoms.
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