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

NCT ID: NCT01998074

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Milk Hypersensitivity Food Sensitivity Protein Allergy

Keywords

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Cow's Milk protein Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Study formula

Group Type EXPERIMENTAL

extensively hydrolyzed rice protein formula

Intervention Type DIETARY_SUPPLEMENT

Interventions

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extensively hydrolyzed rice protein formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair Ziekenhuis

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24914098 (View on PubMed)

Other Identifiers

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BUN 143201010095

Identifier Type: OTHER

Identifier Source: secondary_id

UP2010-Paradice

Identifier Type: -

Identifier Source: org_study_id