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Certain lactic acid bacteria may accelerate recovery from acute diarrhea. Lactobacillus reuteri is a commonly occurring Lactobacillus species with therapeutic potential in diarrhea.Prospective, randomized, placebo-controlled trial in two hospitals.Children between 6 and 36 months of age admitted for rotavirus-associated diarrhea were randomized into three groups to receive either 1010 or 107 colony-forming units (cfu) of L. reuteri or a matching placebo once a day for up to 5 days.The main effect of L. reuteri was on the duration of watery diarrhea. The mean (±SD) duration of watery diarrhea after initiation of treatment was 2.5 (1.5) days in the placebo group (n = 25) vs. 1.9 (0.9) days in the small dosage (n = 20) and 1.5 (1.1) days in the large dosage (n = 21) L. reuteri recipients (P = 0.01). By the second day of treatment watery diarrhea persisted in 80% of the placebo, 70% of the small dosage and 48% of the large dosage L. reuteri recipients (P = 0.04, large dosage vs. placebo). Stool cultures for lactobacilli confirmed that administration of L. reuteri resulted in good colonization of the GI tract. The mean (±SD) of total Lactobacillus count 2 days after treatment initiation was 2.8 (1.6) log 10 cfu/g in the placebo group, 4.5 (2.0) log 10 cfu/g in the small dosage L. reuteri group and 6.1 (1.2) log 10 cfu/g in the large dosage L. reuteri group (P = 0.0004).L. reuteri effectively colonized the gastrointestinal tract after administration and significantly shortened the duration of watery diarrhea associated with rotavirus. There was a correlation between the dosage of L. reuteri and the clinical effect.