Efficacy and Safety of A Compound Fructose-oligosaccharide Fiber Granule for Functional Constipation: A Parallel, Randomized, Controlled, Double-blind Study / 胃肠病学

ABSTRACT

Background: Dietary fiber is strongly recommended as the basic treatment for functional constipation according to global guidelines. However, a complete evaluation standard for the laxative functional food remains to be improved in China. Aims: To evaluate the efficacy and safety of the laxative function of a compound fructose-oligosaccharide fiber granule, so as to provide evidence-based medical basis for the evaluation of laxative functional food. Methods: In a randomized, double-blind, parallel and controlled trial with placebo as control, 120 subjects with functional constipation were enrolled in 2 clinical research centers in Beijing, and randomly divided into experimental group and control group (60 cases in each group). Subjects in experimental group were given a compound fructose-oligosaccharide fiber granule dissolved in 50 mL water orally, 1 bag (9 g) per day for 2 weeks; while those in control group were given a placebo granule with the same appearance, specification and dosage as the experimental group. The bowel movement frequency per week, defecation status and stool consistency were recorded before and after the test, and the safety tests were completed. Results: After 2 weeks of treatment, the bowel movement frequency in experimental group increased by (1.63±1.57) times per week, the stool consistency assessed by Bristol stool form scale and the difficulty in defecation were also improved as compared with the baseline (all P<0.05). Furthermore, improvements in experimental group were superior to those in control group (all P<0.05). No allergic and other adverse events were reported during the test, and there were no significant changes in blood, urine, stool routine and blood biochemical indices before and after the test. Conclusions: The compound fructose-oligosaccharide fiber granule tested in this study is proved to have laxative effect and is safety for functional constipation. The testing program is scientific and of feasibility, and may provide a methodology basis for human oral administration trials of laxative functional food.