Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Study Overview
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Brief Summary
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Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Official Title
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Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Other: Test extensively hydrolyzed formula
* Other: Control extensively hydrolyzed formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at term (>36 weeks gestation) 2 months to <4 years of age at enrollment Documented CMA within 6 months prior to enrollment Otherwise healthy 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 Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)) Immunodeficiency Receiving free amino acid formula 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: 4 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 |
| --- | --- |
| Active Comparator: Test then Control<br>Subjects will perform a DBPCFC with the Test formula followed by the Control formula | Other: Test extensively hydrolyzed formula<br>* extensively hydrolyzed formula made with a new enzyme<br>Other: Control extensively hydrolyzed formula<br>* commercially available extensively hydrolyzed formula<br>|
| Active Comparator: Control then Test<br>Subjects will perform a DBPCFC with the Control formula followed by the Test formula | Other: Test extensively hydrolyzed formula<br>* extensively hydrolyzed formula made with a new enzyme<br>Other: Control extensively hydrolyzed formula<br>* commercially available extensively hydrolyzed formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic reaction | number of children who react during a DBPCFC to either formula | 2 hours post-DBPCFC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool characteristics | stool descriptors as collected on daily diaries | 1 week | 
| formula intake | amount of formula ingested as collected on daily diaries | 1 week | 
| adverse events | any adverse event reported by caregivers | 1 week |