Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Study Overview
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Brief Summary
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This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

Official Title
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Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Other: Experimental Extensively Hydrolyzed Formula
* Other: Placebo Extensively Hydrolyzed Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment: Documentation of milk-specific serum IgE >15 kIUA/L or > 5 kIUA/L if younger than 1 year. Documented cow's milk skin prick test mean wheal >10mm Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms. Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges. Participant had followed a strict cow's milk protein-free diet prior to enrollment. Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study. Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study. Exclusion Criteria: Participant is exclusively breastfed at the time of enrollment. Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula. Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases or abnormalities other than CMA, immunodeficiencies, unstable asthma, asthma treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema. Previous severe anaphylactic reaction to cow's milk within the last two years. An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test. Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent. Participant is routinely consuming baked milk products.

Ages Eligible for Study
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Minimum Age: 3 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Extensively Hydrolyzed Formula<br>Administered during food challenge and at home feeding period | Other: Experimental Extensively Hydrolyzed Formula<br>* experimental powder formula<br>|
| Placebo Comparator: Placebo Extensively Hydrolyzed Formula<br>Administered during food challenge | Other: Placebo Extensively Hydrolyzed Formula<br>* placebo powder formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Challenge Positive Reactions | Percent of positive food challenge reactions to the experimental formula | Food Challenge Day 1 to Food Challenge Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experimental Formula Intake | Parent completed diaries of formula intake | Home Feeding Day 1 to Day 7 | 
| Food Intake | Parent completed diaries | Home Feeding Day 1 to Day 7 | 
| Gastrointestinal Symptoms | Parent completed diaries | Home Feeding Day 1 to Day 7 | 
| Medication Use | Parent completed diaries | Home Feeding Day 1 to Day 7 | 
| Food Challenge Positive Reactions | Percent of positive food challenge reactions to the experimental formula | Home Feeding Day 1 to Day 7 |