Synbiotic containing Bacillus coagulans and fructo-oligosaccharides for functional abdominal pain in children

Abstract

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, Unique IS-2, 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. CONCLUSION: The synbiotic containing Bacillus coagulans and FOS seems to be effective in the treatment of childhood FAP. Further trials are recommended in this regard.