O0026 RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL OF EFFICACY OF SOY POLYSACCHARIDE FIBER IN CHRONIC FUNCTIONAL CONSTIPATION IN CHILDREN

Abstract

Introduction: To evaluate the efficacy of soy polysaccharide fiber supplement as a treatment for functional chronic constipation in children over two years old. Methods: A randomized, double-blind, placebo-controlled trial was carried out, with duration of six weeks. For sample size calculation, it was estimated an effect size of 42.5% to the intervention group. The patients were randomly assigned to receive soy polysaccharide fiber supplement (N = 15) or placebo (extract of soy; N = 15). The supplement dose was defined according to age (10 to 20 g/day). The two formulae had similar appearance, color, taste and smell and its containers had the same label. An auxilary researcher, not involved in the study design, gave the formulae to each children, according to their entry order. No recommendation was done to alter the usual diet. A 3-day food record evaluated the dietary fiber intake on usual diet before and after our study. Colonic transit time was assessed before and after intervention by means of radiopaque markers. Response to intervention was determined by clinical criterion. The primary outcome measure was defined as clinical improvement (at least two symptoms resolved) or constipation maintenance (inicial symptoms maintened or improvement in only one), following the criterion for functional chronic constipation diagnosis. Results: At the end of study, the dietary fiber intake (diet + supplement) was greater at intervention group (19.3 g/day) than at the placebo one (6.4 g/day) (p < 0.05) among the groups with regard to total colonic transit time [71.0 (47.0 – 101.0) and 51.0 (40.0 – 122.0) hours], right colonic transit time [15.0 (9.0 – 28.0) and 9.0 (7.0 – 23.0) hours], left colonic transit time [30.0 (11.0 –44.0) and 19.0 (9.0 – 31.0) hours] and rectosigmoid transit time [25.0 (13.0 – 36.0) and 25.0 (7.0 – 36.0) hours], respectively, at the end of the intervention. Conclusion: The soy polysaccharide fiber supplement did not present efficacy in treatment of functional chronic constipation. There were no statistically significant differences among the groups with regard to segmental and total colonic transit times at the end of the intervention.