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

Phase 4

Completed

• Conditions: Gas Pain Related Intake
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: α-galactosidase

• Registration Number: NCT01595932
• Lead Sponsor: Azienda Policlinico Umberto I

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 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Last Update Submitted: 2012-05-09
• Study First Posted: 2012-05-10
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
α-galactosidase	α-galactosidase	-

Primary Outcome Measures

Name	Time	Method
Efficacy	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).

Secondary Outcome Measures

Name	Time	Method
Clinical tolerability	treatment: 2 weeks	Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment
Efficacy	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).