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

Sponsor
Azienda Policlinico Umberto I (Other)
Overall Status
Completed
CT.gov ID
NCT01595932
Collaborator
(none)
52
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Jun 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [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 [treatment: 2 weeks]

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

    2. Efficacy [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 [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

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Azienda Policlinico Umberto I

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    May 10, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
    irritable bowel syndrome (IBS)
    bloating
    abdominal distension
    flatulence
    α-Galactosidase

    Study Results

    No Results Posted as of May 10, 2012