Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Study Overview
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Brief Summary
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Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.

Detailed Description
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Specifically, subjects who have CM allergy will be enrolled. The investigators will perform an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care. The investigators will perform allergy skin testing, specific IgE measurement, other serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups at baseline and over time.

Official Title
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Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Conditions
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Food Allergy

Intervention / Treatment
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* Other: Partially Hydrolyzed Whey formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 0.5-18 years old positive skin prick tests (SPT) or detectable serum milk specific IgE and a history of an allergic reaction to milk within 6 months before study screening; or milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2 years old, sIgE >2 kU/L; if > 2 years old, a level >5 kU/L; SPT wheal diameter ≥ 3 mm) a clinical reaction during the cows milk oral food challenge Exclusion Criteria: negative SPT and undetectable milk-specific sIgE unstable asthma, allergic rhinitis, or atopic dermatitis milk-induced eosinophilic gastroenteropathy recent reaction to partially hydrolyzed whey formula history of severe anaphylaxis with hypotension to cows milk participation in any interventional study for the treatment of food allergy in the 6 months prior to screening visit inhalant allergent immunotherapy that has not yet reached maintenance dosing inability to discontinue antihistamines for skin testing, OFC any systemic therapy which in the judgment of the investigator could be immunomodulatory in the 12 months prior to visit 1 (xolair, rituximab, chronic steroids, etc) investigational drug use 90 days prior to visit 1 or intention to use during study period the presence of any medical condition that the investigator deems incompatible with participation in the trial. unable to understand and speak English

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: partially hydrolyzed whey formula<br>The group of patients who pass an oral food challenge to partially hydrolyzed whey formula and will be continued on it through out the study | Other: Partially Hydrolyzed Whey formula<br>* Patients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance.<br>* Other names: Gerber Good Start Formula;|
| No Intervention: No intervention<br>Patients who do not pass an oral food challenge to partially hydrolyzed whey formula will continue on their prior diet of cows milk avoidance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of partially hydrolyzed whey formula tolerance | Prevalence of partially hydrolyzed whey formula tolerance in cow's milk allergic patients - Identify patients who are cow's milk allergic but can tolerate a partially hydrolyzed whey formula | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of cows milk allergy | Determine if ingestion of partially hydrolyzed whey formula accelerates the resolution of allergy to cow's milk. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Allergy, Cows Milk Allergy