Status:
COMPLETED
Sublingual Milk Immunotherapy in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ESPCI Paris
URC-CIC Paris Descartes Necker Cochin
Conditions:
Cow Milk Allergy
Eligibility:
All Genders
5-17 years
Phase:
NA
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 pat...
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 NeocatePasteuriz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00874627
Start Date
September 1 2008
End Date
December 1 2012
Last Update
December 16 2025
Active Locations (1)
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1
Hospital Cochin - Saint-Vincent de Paul
Paris, France, 75679