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Efficacy and tolerability of ?-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial.

ABSTRACT: Gas-related symptoms represent very common complaints in children. The reduction of gas production can be considered as a valuable target in controlling symptoms. ?-galactosidase has been shown to reduce gas production and related symptoms in adults. To evaluate the efficacy and tolerability of ?-galactosidase in the treatment of gas-related symptoms in pediatric patients.Single center, randomized, double-blind, placebo-controlled, parallel group study performed in tertiary care setting. Fifty-two pediatric patients (32 female, age range 4-17) with chronic or recurrent gas-related symptoms were randomized to receive placebo (n?=?25) or ?-galactosidase (n?=?27). Both treatments were given as drops or tablets, according to body weight for 2 weeks. The primary endpoint was the reduction in global distress measured by the Faces Pain Scale-Revised (FPS-R) at the end of treatment compared to baseline. Secondary endpoints were the reduction in severity and frequency of gas-related symptoms as recorded by parents and/or children.?-galactosidase significantly reduced global distress (p?=?0.02) compared to placebo. The digestive enzyme decreased the number of days with moderate to severe bloating (p?=?0.03) and the proportion of patients with flatulence (p?=?0.02). No significant differences were found for abdominal spasms and abdominal distension. No adverse events were reported during treatment.Although larger and longer trials are needed to confirm this result, ?-galactosidase seems to be a safe, well tolerated and effective treatment for gas-related symptoms in the pediatric population.ClinicalTrials.gov, NCT01595932.

SUBMITTER: Di Nardo G

PROVIDER: S-EPMC3849317 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial.

Di Nardo Giovanni G Oliva Salvatore S Ferrari Federica F Mallardo Saverio S Barbara Giovanni G Cremon Cesare C Aloi Marina M Cucchiara Salvatore S

BMC gastroenterology 20130924

<h4>Background</h4>Gas-related symptoms represent very common complaints in children. The reduction of gas production can be considered as a valuable target in controlling symptoms. α-galactosidase has been shown to reduce gas production and related symptoms in adults. To evaluate the efficacy and tolerability of α-galactosidase in the treatment of gas-related symptoms in pediatric patients.<h4>Methods</h4>Single center, randomized, double-blind, placebo-controlled, parallel group study performe ...[more]

PMID: 24063420

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Dataset Information

Efficacy and tolerability of ?-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial.

Publications

Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial.

Similar Datasets

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