Sublingual Milk Immunotherapy in Children
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      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: 
      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
    

Intervention name(s): Milk; Milk
Intervention type(s): Other; Other
Intervention description(s): sublingual administration of milk; placebo
Other intervention name(s): sublingual administration of milk; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: children > 5 years old; IgE-mediated; cow milk allergy; IgE-mediated cow milk allergy persisting after 5 years