Sublingual Milk Immunotherapy in Children

Study Overview
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Brief Summary
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Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The hypothesis is that such process may be applied to food allergy, more precisely to milk. A previous series of 8 patients indicates the likely effectiveness of this technique (Allergy, 2006).

Detailed Description
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National study of current practice, multicentric, randomized, open All oral provocation tests will be randomized, double blind Study treatment. For oral provocation test, placebo with NeocatePasteurized half skimmed milk (available in standard outlets) from 0.1 to 0.8 mL/day Tests At M0 :1) Clinical examination 2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN , casein, BETALACTOGLOBULIN and goat milk using RASTSpecific secretory IgA by ESPCI (frozen saliva)Biologic collection- Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN, quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum). Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days At M3 : clinical examination, side effects during the 3 preceding months At M6 :1) Clinical examination 2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN and goat milk using RAST Specific secretory IgA by ESPCI (frozen saliva)Biologic collection Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN, quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum). Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days At M12 :1) Clinical examination2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN and goat milk using RAST Specific secretory IgA by ESPCI (frozen saliva)Biologic collection- Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN , quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum). Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days

Official Title
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Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Other: Milk
* Other: Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children, male and female Children > 5 years Children with IgE-mediated cow milk allergy, with detectable specific IgE (> 0.10 KU/l) and an immediate type reaction during oral provocation test for a cumulated dose < 100 mL of milk). Children and parents or tutors having given their informed consent after complete information Exclusion Criteria: Children participating or having already participated to a drug trial during the 3 preceding months Children with immune deficiency Children with disabling disease, preventing from a correct practice of sublingual treatment Children receiving steroid therapy Children refusing to participateSevere food neophobia Reaction to placebo during the double blind oral provocation test Severe anaphylactic reaction with milk during the 6 preceding months

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Administration of Milk | Other: Milk<br>* sublingual administration of milk<br>* Other names: sublingual administration of milk;|
| Placebo Comparator: Placebo<br>meals without milk | Other: Milk<br>* placebo<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive milk dose at inclusion, at 6 months and at 12 months |  | at inclusion, at 6 months and at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction at inclusion at 6 months and at 12 months |  | at inclusion at 6 months and at 12 months | 
| Specific IgE rate at inclusion, at 6 months and at 12 months |  | at inclusion, at 6 months and at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children > 5 years old, IgE-mediated, cow milk allergy, IgE-mediated cow milk allergy persisting after 5 years