synbiotic containing bacillus coagulans and fructo-oligosaccharides for functional abdominal pain in children

aim : we evaluated the effectiveness of a synbiotic in the treatment of childhood functional abdominal pain (fap). background: probiotics are effective in the treatment of functional gastrointestinal disorders in adult patients, but there is lack of information in children. patients and methods: children with fap, based on the rome iii criteria ( n = 115, aged 6-18 years), were randomized to receive either synbiotic ( bacillus coagulans, 150 million spore plus fos, 100 mg) twice daily or placebo for four weeks. treatment response was defined as ? 2 point reduction in the 6-point self-rated pain scale or “no pain”. physician-rated global severity and improvement were also evaluated. patients were followed for a total of 12 weeks. results: eighty eight patients completed the trial (45 with synbiotic). response rate was higher with synbiotic than placebo after medication (60% vs. 39.5%, p = 0.044), but was not different between the two groups at week 12 (64.4% vs. 53.4%, p = 0.204). difference between the two groups regarding the physician-rated global severity over the study period was not statistically significant (z = -1.87, p = 0.062). there was no significant difference between the two groups in physician-rated global improvement (week 4, p = 0.437; week 12, p = 0.111). receiving synbiotic (or 2.608, 95% ci: 1.01, 6.68) and baseline pain score (or 2.21, 95% ci: 1.19, 4.10) were predictors of treatment response after medication. conclusions: the synbiotic containing bacillus coagulans and fos is effective in the treatment of childhood fap. further trials are recommended in this regard.