NCT01595932

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Gas Pain Related Intake

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	α-galactosidase	Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children \< 20kg: 4 drops; children \> 20kg and \< 40kg: 8 drops; children \> 40kg: 1 tablet.
DIETARY_SUPPLEMENT	Placebo	Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children \< 20kg: 4 drops; children \> 20kg and \< 40kg: 8 drops; children \> 40kg: 1 tablet.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2012-05-10
• Last updated: 2012-05-10