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

Primary Purpose

Milk Hypersensitivity, Food Sensitivity, Protein Allergy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
extensively hydrolyzed rice protein formula
Sponsored by
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Milk Hypersensitivity focused on measuring Cow's Milk protein Allergy

Eligibility Criteria

2 Weeks - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study formula

Arm Description

Outcomes

Primary Outcome Measures

Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

Secondary Outcome Measures

Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Growth (weight, height, head circumference)
Growth (weight, height, head circumference)
Growth (weight, height, head circumference)

Full Information

First Posted
November 22, 2013
Last Updated
November 27, 2013
Sponsor
United Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01998074
Brief Title
Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy
Acronym
Paradice
Official Title
Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Hypersensitivity, Food Sensitivity, Protein Allergy
Keywords
Cow's Milk protein Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A

8. Arms, Groups, and Interventions

Arm Title
Study formula
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
extensively hydrolyzed rice protein formula
Primary Outcome Measure Information:
Title
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame
at 4 weeks
Secondary Outcome Measure Information:
Title
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame
at 3 months
Title
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time Frame
at 6 months
Title
Growth (weight, height, head circumference)
Time Frame
1 month
Title
Growth (weight, height, head circumference)
Time Frame
3 months
Title
Growth (weight, height, head circumference)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitair Ziekenhuis
City
Brussel
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24914098
Citation
Vandenplas Y, De Greef E, Hauser B; Paradice Study Group; Paradice Study Group. An extensively hydrolysed rice protein-based formula in the management of infants with cow's milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014 Oct;99(10):933-6. doi: 10.1136/archdischild-2013-304727. Epub 2014 Jun 9.
Results Reference
derived

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

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