Investigation of the efficacy of synbiotics in the treatment of functional constipation in children: a randomized double-blind placebo-controlled study.

BACKGROUND/AIMS The aim of this study was to demonstrate the efficacy of synbiotic (Lactobacillus casei, L. rhamnosus, L. plantarum, and Bifidobacterium lactis and prebiotics [fiber, polydextrose, fructo-oligosaccharides, and galacto-oligosaccharides]) treatment in children with functional constipation. MATERIALS AND METHODS This study was performed in patients aged 4-18 years, and the patients were diagnosed to have functional constipation according to the Roma III diagnostic criteria. In this prospective study, the first group received synbiotic and the second group received a placebo. At the end of 4 weeks, patients were questioned about the initial symptoms. Patients who showed improvement in the initial symptoms at the end of the 4-week treatment period were considered to completely benefit from the treatment and those with some improvement in initial symptom were considered to partially benefit from the treatment. RESULTS The synbiotic and placebo groups comprised 72 and 74 patients, respectively. The mean age in the whole study group was 9.18±3.48 years with a male:female ratio of 1:21. After 4 weeks of treatment, significant improvement was not observed in any of the findings in the placebo group. Conversely, a significant improvement was observed in the weekly number of defecations, abdominal pain, painful defecation, and pediatric Bristol scale (p≤0.001) in the synbiotic group. Complete benefit from the treatment was achieved in 48 (66.7%) and 21 (28.3%) patients in the synbiotic and placebo groups, respectively, and a significant difference was observed between the groups (p≤0.001). CONCLUSION Our studies have shown that the use of synbiotics in the treatment of functional constipation in children is beneficial.