Specific Oral Tolerance Induction to Cow's Milk Allergy

This study has been completed.
Sponsor:
Information provided by:
Valencia University General Hospital
ClinicalTrials.gov Identifier:
NCT01199484
First received: September 9, 2010
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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:

  Eligibility

Ages Eligible for Study:   24 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199484

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

No publications provided

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

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:
Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014