Extensively Hydrolyzed Formula: Hypoallergenicity

Study Overview
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Brief Summary
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The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Official Title
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Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula

Conditions
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Food Hypersensitivity

Intervention / Treatment
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* Other: Extensively hydrolyzed, whey protein infant formula
* Other: Extensively hydrolyzed, casein protein infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at term (>36 weeks gestation) Two (2) months to ≤ 12 years of age at enrollment Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by: Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR Results of laboratory tests highly predictive of clinical reactivity to milk Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR, Skin prick tests mean wheal >10 mm Otherwise healthy If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase Having obtained his/her legal representative's informed consent. Exclusion Criteria: Children consuming mother's milk at the time of inclusion and during the trial Any chromosomal or major congenital anomalies Any major gastrointestinal disease or abnormalities other than CMA Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable) Immunodeficiency Receiving free amino acid formula Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable) Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay) Unstable asthma Severe uncontrolled eczema Recent ( within the last 3 months) severe anaphylactic reaction to milk Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol Currently participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 2 Months
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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Formula<br>New hydrolyzed whey formula | Other: Extensively hydrolyzed, whey protein infant formula<br>* New hydrolyzed formula<br>* Other names: Baby Formula;|
| Active Comparator: Control Formula<br>Commercially available hydrolyzed infant formula | Other: Extensively hydrolyzed, casein protein infant formula<br>* Commercially available hydrolyzed infant formula<br>* Other names: Baby Formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoallergenicity | To demonstrate that the test formula does not provoke allergenic activity | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive Tolerance |  | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cow's Milk Allergy, CMA