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

Study Overview
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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.

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.

Official Title
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Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Gas Pain Related Intake

Intervention / Treatment
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* Dietary Supplement: α-galactosidase
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Dietary Supplement: Placebo<br>* 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.<br>|
| Experimental: α-galactosidase<br> | Dietary Supplement: α-galactosidase<br>* 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.<br>* Other names: Sinaire;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bloating, irritable bowel syndrome (IBS), abdominal distension, flatulence, α-Galactosidase