Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy (Paradice)

November 27, 2013 updated by: United Pharmaceuticals

Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants between 2 weeks and 6 months old
  • In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

Exclusion Criteria:

  • Exclusively breast fed infants
  • Preterm infants
  • Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
  • Infants fed an amino acid based formula
  • Infants who had an anaphylactic reaction in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study formula
Dietary supplement: extensively hydrolyzed rice protein formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame: at 4 weeks
at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame: at 3 months
at 3 months
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame: at 6 months
at 6 months
Growth (weight, height, head circumference)
Time Frame: 1 month
1 month
Growth (weight, height, head circumference)
Time Frame: 3 months
3 months
Growth (weight, height, head circumference)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (ESTIMATE)

November 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP2010-Paradice
  • BUN 143201010095 (OTHER: Commissie medische ethiek)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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