ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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 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

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



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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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
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