Clinical trials involving probiotics that demonstrate reduction of duration of diarrhea in children

Study designFindingsReference
Children 1 mo to 3 yr of age with acute-onset diarrhea; double-blind, placebo-controlled trial. Group A, oral rehydration plus placebo; group B, oral rehydration plus Lactobacillus GG (at least 1010 CFU/250 ml). After rehydration in the first 4 to 6 h, patients were offered their usual feedings plus free access to the same solution until diarrhea stopped.144 children in group A, 147 in group B. Duration of diarrhea, 71.9 ± 35.8 h in group A vs. 58.3 ± 27.6 h in group B (mean ± SD; P = 0.03). In rotavirus-positive children, diarrhea lasted 76.6 ± 41.6 h in group A vs. 56.2 ± 16.9 h in groups B (P < 0.008). Diarrhea lasted longer than 7 days in 10.7% of group A vs. 2.7% of group B patients (P < 0.01). Hospital stays were significantly shorter in group B than in group A.51
100 children with diarrhea randomly assigned to receive oral rehydration or oral rehydration followed by administration of lyophilized Lactobacillus GG.Duration of diarrhea was reduced from 6 to 3 days in children receiving Lactobacillus GG compared to control; 61 children had proven rotavirus infection.52
71 well-nourished children between 4 and 45 mo of age suffering from diarrhea received oral rehydration then randomly either Lactobacillus GG-fermented milk product, 125 g (1010 CFU) twice daily (group 1); Lactobacillus GG freeze-dried powder, one dose (1010 CFU) twice daily (group 2); or placebo, pasteurized yogurt (group 3), 125 g twice daily for 5 days.Mean [SD] duration of diarrhea after commencing the therapy was significantly shorter in group 1 (1.4 [0.8] days) and in group 2 (1.4 [0.8] days) than in group 3 (2.4 [1.1] days); F = 8.70, P < 0.001.62
After initial oral rehydration, 49 children aged 6 to 35 mo with rotavirus gastroenteritis randomly received either Lactobacillus GG, L. casei subsp. rhamnosus (Lactophilus), or S. thermophilus and L. delbruckii subsp. bulgaricus (Yalacta) twice daily for 5 days.Mean (SD) duration of diarrhea was 1.8 (0.8) days in children who received Lactobacillus GG, 2.8 (1.2) days in those receiving Lactophilus, and 2.6 (1.4) days in those receiving Yalacta (F = 3.3, P = 0.04). The rotavirus-specific immune responses were different, with Lactobacillus GG therapy associated with enhancement of IgA-specific antibody-secreting cells to rotavirus and serum IgA antibody level at convalescent stage.80
In a double-blind, placebo-controlled trial, 55 infants aged 5-24 mo were randomized to receive a standard infant formula or the same supplemented with Bifidobacterium bifidum and S. thermophilus.8 (31%) of the 26 patients who received the control formula and 2 (7%) of 29 who received the supplemented formula developed diarrhea during the course of the study (P = 0.035; Fisher's exact test, two-tailed). 10 (39%) controls and 3 (10%) receiving supplement shed rotavirus at some time during the study (P = 0.025).122
40 children (6-36 mo) with acute diarrhea (75% rotavirus) were randomized to receive 1010 CFU of either L. reuteri or placebo daily for up to 5 days.Mean (SD) duration of watery diarrhea was 1.7 (1.6) days in the L. reuteri group and 2.9 (2.3) days in the placebo group (P = 0.07). On the second day of treatment, only 26% of patients receiving L. reuteri had watery diarrhea, compared with 81% of those receiving placebo (P = 0.0005).131
81 children (1-36 months) hospitalized for reasons other than diarrhea were enrolled in a double-blind trial and randomly assigned to receive Lactobacillus GG (n = 45) at 6 × 109 CFU or placebo (n = 36) twice daily orally for the duration of their hospital stay.Lactobacillus reduced the risk of nosocomial diarrhea (≥3 loose or watery stools/24h) in comparison with placebo (6.7% vs. 33.3%; relative risk, 0.2; 95% CI, 0.06-0.6). The prevalence of rotavirus infection was similar in both groups (20% vs. 27.8%, respectively; relative risk, 0.72; 95% CI, 0.33-1.56). However, the use of Lactobacillus GG compared with placebo significantly reduced the risk of rotavirus gastroenteritis (1 of 45 [2.2%] vs. 6 of 36 [16.7%], respectively; relative risk, 0.13; 95% CI, 0.02-0.79).138