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256 Chapter 12 TABLE 3. Study characteristics of RCTs on probiotics. Significant results are bold. Author, year n (age) Diagnosis Intervention Comparison Duration Outcome Effect Adverse events Banaszkiewicz, 2005 84 (2-16 yrs) <3 bowel movements per week for at least 12 weeks. Lactobacillus rhamnosus GG a + lactulose b + toilet training placebo + lactulose b + toilet training 26 weeks (12 weeks treatment) 1. defecation frequency/week (mean±SD) 2. fecal incontinence/week (mean±SD) 3. straining/week (mean±SD) 4. % treatment success(≥3 spontaneous bowel movements per week with no episodes of fecal soiling) I:6.1±1.8 vs C:6.8±3.1 I:0.8±1.8 vs C:0.3±0.9 I:1.3±1.5 vs C:1.6±1.8 I:72% vs C:68% -no serious adverse effects Coccorullo, 2010 44 (>6mo) Rome III criteria Lactobacillus reuteri c placebo 8 weeks 1. defecation frequency results presented in a graph, actual numbers not reported -no (serious) adverse effects Bu, 2007 41 (33) 1 (<10 yrs) <3 bowel movements per week for >2 months and ≥1 of the following symptoms: anal fissures with bleeding, fecal soiling, or passage of large and hard stool. Lactobacillus casei rhamnosus d Magnesium oxide (MgO) e 4 weeks 1. defecation frequency/day (mean±SD) 2. fecal incontinence/4 weeks (mean±SD) 3. abdominal pain/4 weeks (mean±SD) I:0.6±0.2 vs C:0.6±0.1 I:2.1±3.8 vs C:2.7±5.1 I:1.9±1.6 vs C:4.8±3.7 Lactulose use (1 mL /kg per day) was allowed when no stool passage for 3 days was noted. Glycerin enema was used only when no defecation was noted for >5 days or abdominal pain was suffered due to stool impaction. Lactulose use (1 mL /kg per day) was allowed when no stool passage for 3 days was noted. Glycerin enema was used only when no defecation was noted for >5 days or abdominal pain was suffered due to stool impaction. -no (serious) adverse effects