Tu1398 One Year Treatment of Childhood Constipation Comparing PEG 3350 With Electrolytes Versus PEG 4000: A Double Blind Randomized Controlled Trial

Abstract

Introduction: Bloating, abdominal distension and flatulence represent very frequent complaints in children with irritable bowel syndrome (IBS). These symptoms are frequently associated to excessive intestinal gas. Hence the reduction of gas production can be considered an effective therapeutic strategy. Alpha-Galactosidase has been shown to reduce gas production and related symptoms in adults. Aim: to evaluate the efficacy and tolerability of Alphagalactosidase on gas related symptoms in pediatric IBS patients. Patients and Methods: this was a single center, randomized, double-blind, placebo-controlled, parallel-group study performed in tertiary care setting. Fifty-two pediatric patients (32 female, median age 8 yrs, range 4-17) with IBS according to Rome III criteria were randomized to receive placebo (n = 25) or Alpha-galactosidase (n = 27) (Sinaire, Promefarm). Both treatments were given as drops or tablets according to body weight at the beginning of each of three meals for 2 weeks. Children were followed up two weeks after the end of treatment. Parent and/or selfassessment of the severity of gas related symptoms (bloating, flatulence, abdominal distension and abdominal spasms) were recorded 3 times daily during the treatment period using a validated visual score. The primary endpoint was reduction in the severity of bloating at the end of treatment compared to baseline. Secondary endpoints were reduction in the severity of other symptoms. As a measure of intestinal gas production, breath hydrogen concentration was measured at baseline and at the end of treatment. Results: α-galactosidase significantly reduced the severity of bloating (p = 0,023) and flatulence (p = 0,005) as compared with placebo. No significant differences were found for abdominal spasms and abdominal distension. The administration of Alpha-galactosidase had no significant effect on breath hydrogen excretion as compared with placebo (p = 0,54). The benefical effects of treatment tended to disappear in both groups at the end of follow-up. No treatmentrelated adverse events were reported during treatment. Conclusions: Although larger and longer trials are needed to confirm our results, Alpha-galattosidase looks a safe and effective agent for managing gas related symptoms in pediatric IBS.