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 ]

Global distress associated with gas-related symptoms (bloating, flatulance, abdominal distension and abdominal spasm): data collected by parents or patients on a daily diary chart, 3 time/daily by using a validated visual score scale (Faces Pain Scale-Revised).


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