Sublingual Milk Immunotherapy in Children

Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00874627

Acronym

Lactaide

Enrollment

Registered

2009-04-02

Start date

2008-09-30

Completion date

2012-12-31

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Keywords

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

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

Interventions

OTHERMilk

sublingual administration of milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reactive milk dose at inclusion, at 6 months and at 12 months	at inclusion, at 6 months and at 12 months

Secondary

Measure	Time frame
Skin reaction at inclusion at 6 months and at 12 months	at inclusion at 6 months and at 12 months
Specific IgE rate at inclusion, at 6 months and at 12 months	at inclusion, at 6 months and at 12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026