Lactobacillus GG administered in oral rehydration solution to children with acute diarrhea: A multicenter European trial

Background: The probiotic Lactobacillus GG is effective in promoting a more rapid recovery of acute, watery diarrhea in children with rotavirus enteri tis. Very limited information is available, however, on the potential role of such agents in non-rotaviral diarrheal episodes. Furthermore, no evidenc e is available concerning the efficacy of Lactobacillus GG administered in the oral rehydration solution during oral rehydration therapy. A multicente r trial was conducted to evaluate the efficacy of Lactobacillus GG administ ered in the oral rehydration solution to patients with acute-onset diarrhea of all causes. Methods: Children 1 month to 3 years of age with acute-onset diarrhea were enrolled in a double-blind, placebo-controlled investigation. Patients were randomly allocated to group A, receiving oral rehydration solution plus pl acebo, or group B, receiving the same preparation but with a live preparati on of Lactobacillus GG (at least 10(10) CFU/250 mi). After rehydration in t he first 4 to 6 hours, patients were offered their usual feedings plus free access to the same solution until diarrhea stopped. Results: One hundred forty children were enrolled in group A, and 147 in gr oup B. There were no differences at admission between the groups in age, se x, previous types of feeding, previous duration of diarrhea, use of antibio tics, weight, height, weight-height percentile, prevalence of fever, overal l status, degree of dehydration, and percentage of in- versus outpatients. Duration of diarrhea after enrollment was 71.9 +/- 35.8 hours in group A ve rsus 58.3 +/- 27.6 hours in group B (mean +/- SD; P = 0.03). In rotavirus-p ositive children, diarrhea lasted 76.6 +/- 41.6 hours in group A versus 56. 2 +/- 16.9 hours in groups B (P < 0.008), Diarrhea lasted longer than 7 day s in 10.7% of group A versus 2.7% of group B patients (P < 0.01). Hospital stays were significantly shorter in group B than in group A. Conclusions: Administering oral rehydration solution containing Lactobacill us GG to children with acute diarrhea is safe and results in shorter durati on of diarrhea, less chance of a protracted course, and faster discharge fr om the hospital. (C) 2000 Lippincott Williams & Wilkins, Inc.