Sublingual Milk Immunotherapy in Children

Overview

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).

Full Title of Study: “Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2012

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

Interventions

  • Other: Milk
    • sublingual administration of milk
  • Other: Milk
    • placebo

Arms, Groups and Cohorts

  • Experimental: Experimental
    • Administration of Milk
  • Placebo Comparator: Placebo
    • meals without milk

Clinical Trial Outcome Measures

Primary Measures

  • Reactive milk dose at inclusion, at 6 months and at 12 months
    • Time Frame: at inclusion, at 6 months and at 12 months

Secondary Measures

  • Skin reaction at inclusion at 6 months and at 12 months
    • Time Frame: at inclusion at 6 months and at 12 months
  • Specific IgE rate at inclusion, at 6 months and at 12 months
    • Time Frame: at inclusion, at 6 months and at 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • ESPCI Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christophe Dupont, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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