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

Azienda Policlinico Umberto I

Status and phase

Completed

Phase 4

Conditions

Gas Pain Related Intake

Treatments

Dietary Supplement: α-galactosidase

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01595932

α-galactosidase

Details and patient eligibility

About

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

Full 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.

Enrollment

52 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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.