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

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ClinicalTrials.gov Identifier: NCT01595932
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gas Pain Related Intake Dietary Supplement: α-galactosidase Dietary Supplement: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010
Arms and Interventions
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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 Name: Sinaire


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy [ Time Frame: 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 :
  1. Clinical tolerability [ Time Frame: treatment: 2 weeks ]
    Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment

  2. Efficacy [ Time Frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) ]

    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.


  3. Efficacy [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01595932    
Other Study ID Numbers: α-galactosidase
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Keywords provided by Giovanni Di Nardo, Azienda Policlinico Umberto I:
irritable bowel syndrome (IBS)
bloating
abdominal distension
flatulence
α-Galactosidase