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Completed

NCT Number: NCT01595932

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

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

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Key information

Conditions

Gas Pain Related Intake Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Flatulence Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

α-galactosidase

Dietary Supplement

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

Placebo

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 10, 2012
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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