Clinical trial NCT00874627: Sublingual Milk Immunotherapy in Children
Official title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Keywords: children > 5 years old
IgE-mediated
cow milk allergy
IgE-mediated cow milk allergy persisting after 5 years
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ESPCI Paris
First posted: 2009-04-02
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Reactive milk dose at inclusion, at 6 months and at 12 months
timeFrame: at inclusion, at 6 months and at 12 months
Secondary outcomes:
measure: Skin reaction at inclusion at 6 months and at 12 months
timeFrame: at inclusion at 6 months and at 12 months
measure: Specific IgE rate at inclusion, at 6 months and at 12 months
timeFrame: at inclusion, at 6 months and at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Cochin - Saint-Vincent de Paul
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christophe Dupont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: