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258 Chapter 12 TABLE 4. Study characteristics of RCT on synbiotics. Significant results are bold. Author, year n (age) Diagnosis Interventions Duration Outcome Effect Comments Khodadad, 2010 97 (4-12 yrs) Rome III criteria Group A: liquid paraffin a + placebo; Group B: synbiotic b + placebo; Group C: liquid paraffin a + synbiotic b ; All groups received toilet training advice. 4 weeks 1. defecation frequency/week (mean±SD) 2. fecal incontinence/week (mean±SD) 3. % painful defecation 4. abdominal pain 5. successful treatment (≥3 bowel movements per week and ≤2 fecal incontinence episodes in the last month with no abdominal pain) A:6.8±2.6 vs B:5.2±1.9 vs C:7.5±4.4 A:0.2±1.3 vs B:0.1±0.3 vs C:0.0±0.0 A:7% vs B:10% vs C:11% A:14% vs B:7% vs C:14% A:83% vs B:71% vs C:76% -seepage of oil was reported in the majority of children in groups A and C, no adverse effects in group B. -no serious adverse effects. a 1.5 ml/kg/day oral b Synbiotic consisted of probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and fructooligosaccharide as prebiotic (1x10 9 colony-forming units/ sachet). 1 sachet per day.