Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children

Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial

The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.

Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.

Dietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.

Literature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.

Inclusion Criteria:

• pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.

Exclusion Criteria:

• suspected episodes of hypersensitivity or allergy;
• chronic organic disorders (by clinical history, physical examination, laboratory tests);
• use of drug affecting the GI motility during the previous 4 weeks;
• inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.