Results of a randomized placebo-controlled study of the clinical effectiveness of a beverage with lactulose, inulin, prune and fennel extract in treatment of functional constipation in children
The objective. To study the effectiveness of using and tolerance of a dietary supplement (DS) «KidZ drink with prune» with lactulose, inulin, prune and fennel extract in complex therapy of functional chronic constipation in children. Patients and methods. The study included 60 children (boys and girls) aged 3-14 years diagnosed with «compensated functional chronic constipation». The patients were randomized into 2 groups, 30 in each. All patients received recommendations about diet regimens, bowel movements and physical activity. Patients from the main group received «KidZ drink with prune», control group received a placebo «KidZ drink with prune» for 30 days. Children received no other medications with laxative and/or pre- and probiotic effects. All participants were examined in inpatient department. Before the study, then after 30 and 60 days, clinical assessment of symptoms was undertaken: number of bowel movements per week, stool consistency; presence/absence and severity of symptoms of constipation; tolerance of the preparation and terms of coping with constipation symptoms. Also, intestinal microbiocenosis was assessed bacteriologically. Data were analysed using a statistical software package. Results. Against the background of therapy with inclusion of «KidZ drink with prune» normalisation of stool consistency and frequency was noted in most children, along with a statistically significant positive dynamics of clinical symptoms, namely, alleviation of abdominal pains, abdominal distention, sensation of incomplete and difficult bowel movement, necessity to strain, meteorism. Analysis of clinical data in patients of the control group who received a placebo labelled «KidZ drink with prune» has shown the absence of a significant dynamics in stool forms, number of bowel movements, dynamics of symptoms. One month afterwards, the landscape of fecal microbiota in patients of the control group was identical with the initial values, whereas in patients of the basic group upon termination of the course of «KidZ drink with prune» a growth of representatives of indigenous flora, in particular, bifidobacteria and lactobacilli and suppression of the growth of conditionally pathogenic representatives of microbiocenosis (haemolysing E. coli, Citrobacter, species Klebsiella pneumoniae) to normal values was found in all children. Conclusion. The results of the study have demonstrated a clinical effectiveness and safety of the dietary supplement «KidZ drink with prune» in 3-14-year-old children with chronic functional constipation in the compensated stage as part of complex therapy. Key words: constipation, treatment, lactulose, inulin, prune, microbiota