Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-30

Brief Summary

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This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged\< 12 years with documented cow's milk protein allergy (CMPA).

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Detailed Description

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Not Provided

Conditions

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Cow's Milk Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New Amino Acid formula

New Amino-Acid based Infant Formula

Group Type EXPERIMENTAL

New Amino Acid formula

Intervention Type OTHER

Ordesa's Amino-Acid based Infant Formula

Control formula

Commercially available Amino Acid Formula

Group Type ACTIVE_COMPARATOR

Commercially available Amino Acid Formula

Intervention Type OTHER

Commercially available Amino Acid Formula

Interventions

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New Amino Acid formula

Ordesa's Amino-Acid based Infant Formula

Intervention Type OTHER

Commercially available Amino Acid Formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

* Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
* Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum \[sIgE\>0,35 KUI/L\] or skin prick test \[SPT ≥ 3 mm\]) OR
* Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
* Aged ≤12 years of age at screening.
* Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
* Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria

* Children who receive breastfeeding at study enrolment.
* Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine \[excluding eye drops\] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
* Severe anaphylactic reaction \[required ≥ 2 doses of epinephrine\] to milk or breast milk within the past 2 years;
* Existing illness that could interfere with formula acceptance or identification of allergic reactions.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No