Clinical Trial: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
Brief 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 Summary:
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.
Sponsor: Azienda Policlinico Umberto I
Current Primary Outcome: Efficacy [ Time Frame: 5 weeks of observation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical tolerability [ Time Frame: treatment: 2 weeks ]Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment
- Efficacy [ Time Frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) ]
Frequency and intensity (6 point scale: 0=absent; 5=very severe)of bloating, flatulance, visible distension, spasms.
Data were collected by parents or patients on a daily diary chart.
- Efficacy [ Time Frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) ]Physician's overall evaluation: 4 point scale (from completed/marked improvement to worse).
Original Secondary Outcome: Same as current
Information By: Azienda Policlinico Umberto I
Dates:
Date Received: May 9, 2012
Date Started: June 2009
Date Completion:
Last Updated: May 9, 2012
Last Verified: May 2012