Sublingual Milk Immunotherapy in Children (Lactaide)
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ClinicalTrials.gov Identifier: NCT00874627 |
Recruitment Status :
Completed
First Posted : April 2, 2009
Last Update Posted : December 11, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cow Milk Allergy | Other: Milk | Not Applicable |
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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental
Administration of Milk
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Other: Milk
sublingual administration of milk
Other Name: sublingual administration of milk |
Placebo Comparator: Placebo
meals without milk
|
Other: Milk
placebo
Other Name: placebo |
- Reactive milk dose at inclusion, at 6 months and at 12 months [ Time Frame: at inclusion, at 6 months and at 12 months ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874627
France | |
Hospital Cochin - Saint-Vincent de Paul | |
Paris, France, 75679 |
Principal Investigator: | Christophe Dupont, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00874627 |
Other Study ID Numbers: |
K070602 |
First Posted: | April 2, 2009 Key Record Dates |
Last Update Posted: | December 11, 2012 |
Last Verified: | December 2012 |
children > 5 years old IgE-mediated cow milk allergy IgE-mediated cow milk allergy persisting after 5 years |
Hypersensitivity Milk Hypersensitivity Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |