Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy

Study Overview
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Brief Summary
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Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%. The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions. Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited. The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.

Official Title
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Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy

Conditions
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Hypersensitivity, Milk

Intervention / Treatment
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* Other: Oral immunotherapy protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels) Exclusion Criteria: children with not IgE-mediated clinical manifestations children with a known immunodeficiency

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral immunotherapy protocol<br>Eligible children receive the oral food challenge (OCD) protocol | Other: Oral immunotherapy protocol<br>* In hospital setting: three increasing doses every 30 minutes of 1ml, 5ml and 10ml of cow milk (CM). Oral food challenge (OFC) stopped at 10ml even if no clinical reactions occurred. At home: every child will take the dose tolerated in hospital, starting the day after the OFC, for 3-4 weeks.Once reached the dose of 40ml of CM without reactions for at least 2 weeks, families increment the dose of 5 ml every week, till the tolerance of 50 ml, then of 10 ml every week, till the tolerance of 100ml and then, of 10 ml every 3 days till the tolerance of 150 ml of milk.<br>* Other names: Oral food challenge (OCD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance | Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical reactions experienced by children at home | Number and types, communicated by parents at a dedicated telephone number. | 6 months | 
| Serum levels of specific IgE | Comparison in serum levels of specific IgE between baseline and the end of the protocol, hypothesizing a decrease of IgE levels after OFC | 6 months | 
| Serum levels of specific IgG4 | Comparison in serum levels of specific IgG4 between baseline and the end of the protocol, hypothesizing an increase of IgG4 levels after OFC | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Hypersensitivity, Milk, Cow's Milk, Immunotherapy