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Specific Oral Tolerance Induction to Cow's Milk Allergy

This study has been completed.
Information provided by:
Valencia University General Hospital Identifier:
First received: September 9, 2010
Last updated: September 10, 2010
Last verified: September 2010

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.

Condition Intervention
Food Hypersensitivity
Other: Cow's milk

Study Type: Interventional
Official Title: Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.

Resource links provided by NLM:

Further study details as provided by Valencia University General Hospital:


Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01199484

Allergy Unit. University General Hospital
Valencia, Spain, 46014
Sponsors and Collaborators
Valencia University General Hospital
  More Information

Responsible Party: Antonio Martorell Aragones, Allergy Unit. University General Hospital Identifier: NCT01199484     History of Changes
Other Study ID Numbers: SOTI-CMA
Study First Received: September 9, 2010
Last Updated: September 10, 2010

Keywords provided by Valencia University General Hospital:
Cow's milk allergy
food allergy
oral desensitization
randomized trial
specific oral tolerance induction.

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate processed this record on May 22, 2017