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

Study Overview
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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).

Detailed Description
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Not Provided

Official Title
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A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Other: New Amino Acid formula
* Other: Commercially available Amino Acid Formula


Participation Criteria
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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.

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Amino Acid formula<br>New Amino-Acid based Infant Formula | Other: New Amino Acid formula<br>* Ordesa's Amino-Acid based Infant Formula<br>|
| Active Comparator: Control formula<br>Commercially available Amino Acid Formula | Other: Commercially available Amino Acid Formula<br>* Commercially available Amino Acid Formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC). Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cow's Milk Allergy Related Symptoms | Cow's Milk Allergy related Symptoms recorded at visit 1 and visit 4 using the Vandenplas symptom-based score (SBS). The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score ≥ 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score <12, the symptoms are less likely related to cow's milk. Look for other causes. | 14 days |