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

Azienda Policlinico Umberto I52 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gas Pain Related Intake

Interventions

α-galactosidaseDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 5 weeks of observation

Secondary Outcomes

Clinical tolerability

Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment

Time frame: 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.

Time frame: 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).

Time frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)

Data from ClinicalTrials.gov

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