Sublingual Milk Immunotherapy in Children (Lactaide)

• ClinicalTrials.gov Identifier: NCT00874627
• Recruitment Status: Completed
• First Posted: April 2, 2009
• Last Update Posted: December 11, 2012
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: ESPCI Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cow Milk Allergy	Other: Milk	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy
• Study Start Date: September 2008
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; Administration of Milk	Other: Milk; sublingual administration of milk; Other Name: sublingual administration of milk
Placebo Comparator: Placebo; meals without milk	Other: Milk; placebo; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

1. Reactive milk dose at inclusion, at 6 months and at 12 months [ Time Frame: at inclusion, at 6 months and at 12 months ]

Secondary Outcome Measures :

1. Skin reaction at inclusion at 6 months and at 12 months [ Time Frame: at inclusion at 6 months and at 12 months ]
2. Specific IgE rate at inclusion, at 6 months and at 12 months [ Time Frame: at inclusion, at 6 months and at 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hospital Cochin - Saint-Vincent de Paul

Paris, France, 75679

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

ESPCI Paris

Investigators

• Principal Investigator: Christophe Dupont, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT00874627
• Other Study ID Numbers: K070602
• First Posted: April 2, 2009
• Last Update Posted: December 11, 2012
• Last Verified: December 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:

children > 5 years old; IgE-mediated; cow milk allergy; IgE-mediated cow milk allergy persisting after 5 years

Additional relevant MeSH terms:

Hypersensitivity; Milk Hypersensitivity; Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate