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Specific Oral Tolerance Induction to Cow's Milk Allergy

NCT ID: NCT01199484

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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 be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.

Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.

Detailed Description

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Conditions

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Food Hypersensitivity

Interventions

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Cow's milk

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. -Infants between 24-36 months of age.
2. -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 )
3. -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.
4. -Written informed consent from the parents.

Exclusion Criteria

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

24 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Allergy Unit. University General Hospital

Locations

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Allergy Unit. University General Hospital

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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SOTI-CMA

Identifier Type: -

Identifier Source: org_study_id