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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gas Pain Related Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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.

α-galactosidase

Group Type EXPERIMENTAL

α-galactosidase

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Sinaire

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No