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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014