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.

Study Overview

• Status: Completed
• Conditions: Gas Pain Related Intake
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: α-galactosidase

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	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.
Experimental: α-galactosidase	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.; Other Names: Sinaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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).	5 weeks of observation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical tolerability	Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment	treatment: 2 weeks
Efficacy	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.	5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Efficacy	Physician's overall evaluation: 4 point scale (from completed/marked improvement to worse).	5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I

Publications and helpful links

General Publications

• Di Nardo G, Oliva S, Ferrari F, Mallardo S, Barbara G, Cremon C, Aloi M, Cucchiara S. Efficacy and tolerability of alpha-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013 Sep 24;13:142. doi: 10.1186/1471-230X-13-142.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: bloating; abdominal distension; flatulence; irritable bowel syndrome (IBS); α-Galactosidase
• Other Study ID Numbers: α-galactosidase