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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01595932
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Gas Pain Related Intake
Dietary Supplement: α-galactosidase
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 5 weeks of observation ] [ Designated as safety issue: No ]
    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:
  • Clinical tolerability [ Time Frame: treatment: 2 weeks ] [ Designated as safety issue: Yes ]
    Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment

  • Efficacy [ Time Frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) ] [ Designated as safety issue: No ]

    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.


  • Efficacy [ Time Frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) ] [ Designated as safety issue: No ]
    Physician's overall evaluation: 4 point scale (from completed/marked improvement to worse).


Enrollment: 52
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided by Azienda Policlinico Umberto I

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01595932     History of Changes
Other Study ID Numbers: α-galactosidase
Study First Received: May 9, 2012
Last Updated: May 9, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Policlinico Umberto I:
irritable bowel syndrome (IBS)
bloating
abdominal distension
flatulence
α-Galactosidase

ClinicalTrials.gov processed this record on April 17, 2014