Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution

Study Overview
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Brief Summary
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Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA. The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.

Conditions
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Food Allergy in Infants, Proctocolitis, Atopic Dermatitis, Reflux, Gastroesophageal, Tolerance

Intervention / Treatment
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* Other: oral food challenge 1
* Other: oral food challenge 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants under 4 months age with delayed symptoms evoking CMPA Exclusion Criteria: exclusively breastfed infants no improvement of symptoms despite amino acid formula patients with symptoms of food protein induced enterocolitis patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet

Ages Eligible for Study
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Maximum Age: 4 Months

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: oral food challenge 1|First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA|
|Other: oral food challenge 2|Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA | We proceed to an elimination-reintroduction test of the culprit food (CMP) in patients with delayed symptoms of non IgE-mediated CMPA (rectal bleeding, atopic dermatitis, reflux, excessive crying, failure to thrive...) after a period of two to eight weeks of exclusion of CMP. If symptoms disappear after CMP elimination, and reappear after CMP reintroduction, the diagnosis of CMPA is confirmed. | 2 to 8 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age of tolerance of confirmed non IgE-mediated CMPA | We proceed to an oral food challenge (OFC) for CMP every 2 months, after the age of 4 months, and after at least 2 months of elimination diet. If symptoms occur after OFC, the patient is still allergic. If no symptom occur after OFC, the patient is considered as tolerant for CMP, and that determine age of tolerance. | after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance |