Specific Oral Tolerance Induction to Cow's Milk Allergy

Status:

COMPLETED

Specific Oral Tolerance Induction to Cow's Milk Allergy

Lead Sponsor:

General University Hospital of Valencia

Conditions:

Food Hypersensitivity

Eligibility:

All Genders

24-36 years

Phase:

Brief Summary

Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should b...

Eligibility Criteria

Inclusion

-Infants between 24-36 months of age.
-IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:
Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
Skin test readings ≥ 3 mm and specific IgE titers \> 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
-Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:
Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) \>0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
-Written informed consent from the parents.

Exclusion

-Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
-Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
-Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
-Patients receiving immunosuppressor therapy.
-Patients receiving beta-blockers (including topical formulations).
-Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01199484

Last Update

September 13 2010

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