MedTrace Logo

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

NCT01595932 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-05-10

No results posted yet for this study

Summary

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

Conditions

  • Gas Pain Related Intake

Interventions

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.

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.

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595932 on ClinicalTrials.gov