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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

September 9, 2010
September 10, 2010
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Complete list of historical versions of study NCT01199484 on ClinicalTrials.gov Archive Site
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Specific Oral Tolerance Induction to Cow's Milk Allergy
Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.

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.

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Interventional
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Food Hypersensitivity
Other: Cow's milk
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
24 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01199484
SOTI-CMA
Yes
Antonio Martorell Aragones, Allergy Unit. University General Hospital
Valencia University General Hospital
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Valencia University General Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP