Comparing the Safety and Efficacy of Two Different Synbiotics in the Treatment of Infantile Functional Constipation Resistant to Non-Pharmacological Therapy: A Randomized Clinical Trial

Background: Recent evidence emphasizes the positive effect of probiotics and synbiotics in the treatment of functional constipation in childhood, but no study has surveyed the effectiveness of synbiotics in improving the clinical conditions in infants ≤6 months suffering from functional constipation, so we performed this study. Aims: Comparing the efficacy and safety of two types of synbiotics including PediLact® (Zist-Takhmir Co., Tehran, Iran) drop containing Bifidobacterium infantis, Lactobacillus reuteri, Lactobacillus rhamnosus plus fructooligosaccharides with BBCare® (Zist-Takhmir Co., Tehran, Iran) drop containing Bifidobacterium lactis BB-12 plus fructooligosaccharides in the treatment of infantile functional constipation. Study Design: This trial was performed on infants less than 6 months of age who met the ROME IV criteria for infantile functional constipation. The patients were randomly assigned to receive PediLact drop (n = 44) or BB-Care drop (n = 45) for one month and were evaluated on the seventh day and at the end of the first month. Results: A significant downward trend was revealed in the responsive rate of every clinical symptom in both intervention groups but BB-Care was more effective than PediLact in improving the frequency of weekly defecation. Both synbiotics also improved significantly all symptoms of constipation in all types of feeding methods after one week and one month of intervention (primary outcomes). There was no side effect of synbiotics through intervention (secondary outcome). Conclusions: This study shows that both synbiotics improved significantly all symptoms of functional constipation after one week and one month of intervention apart from type of feeding method in infants less than 6 months of age. Due to the greater effectiveness of BB-care in increasing stool frequency, B. lactis may play a more prominent role in this age group. This study has been registered at the Iranian Registry of Clinical Trails (IRCT20160827029535N7)